199 Trackwise Jobs - Page 4

Purpose of the Role The Senior Salesforce Administrator is responsible for supporting the overall maintenance of the Salesforce platform. Acting as a central point of orchestration for developers, support teams, as well as end users, the administrator provides critical day to day support for deployment, user setup, data, monitoring, troubleshooting, enhancing, automating, reporting, upgrading and training of the platform. The Admin will also act as a first level SME for the Complaint Handling Process within the Trackwise system Primary Duties and Responsibilities Own the end to end administration of the Salesforce Platform including user management, workflows, and basic validations. Deployment of platform changes, by collaborating with the global platform, application development & support teams Provide expert support with setup and maintenance of reports and dashboards Plan and manage release & upgrade of environments covering Salesforce Seasonal Releases, Trackwise Releases & Regular Change Requests Perform data load activities on demand Support MDR & other Regulatory/Compliance related activities Collaborate with offshore support teams to manage incidents , change requests & integrations Supervision of incidents , change requests & integrations collaborating with the external vendor teams Competencies Development Support: Support new developer onboarding activities Release Execution: Responsible to execute releases from SF, Trackwise & Olympus changes. Issue Resolution: Troubleshoot and resolve complex technical issues in collaboration with development teams and vendor support. Support Key Users and manage their delegated administration Administration of DevOps Infrastructure, Sandbox Management (clone, refresh, etc) & related access Security Review: Support regular security review activities by extracting the relevant reports and working with the Application owner Minimum Qualification Education*: Bachelor’s Degree in IT or Engineering or Computer Applications Experience*: Certified in Salesforce Administration 3+ years in Salesforce Administration & DevOps activities 2+ years with Trackwise or a similar Quality Management System. Skills: Good knowledge of Salesforce architecture and related technologies Good knowledge on SF development best practices, objects Experience with Agile/Scrum Techniques and tools like JIRA. Strong communication (verbal/written/listening) skills. Good organizational skills with an eye for detail and able to work within a team setting. Experience working with and/or driving remote teams across continents and time zones is a huge benefit.

Date: 30 Jun 2025 Location: Bangalore, KA, IN, 560099 Custom Field 1: Essential Functions Role: Lead Maintenance Engineer Job Location: Bangalore Department: Engineering & Maintenance About Syngene: Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene’ s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose: Leading EAM team & activities at SU3. Execute maintenance and Upgradation projects. Ensures Safety & GMP compliance at SU3. Common Responsibilities Responsible for EAM activities in the Biologics Operations Unit Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time. Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms. Specific Responsibilities Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development. Able to handle minor project, design review and execute and Facility modification in a GMP facility. Exposure in handling Process, Electrical, HVAC, Utilities and instrumentation teams. Ensuring the related facility, equipment and maintenance systems are in GMP compliance state. Adherence to established procedures and policies of the company on Quality and Safety, ensuring the team adheres the same. Responsible for managing maintenance activities within framework of Quality management systems. Ensuring work management through defined SOP’s, Change control, deviations and CAPA, review and approval through Trackwise and EDMS. Represent the function during audits and ensuring agreed actions are acted upon timely. Ensure followings are complying: Equipment master list, Preventive Maintenance and calibration planners are prepared timely. Preventive maintenance and Calibration of equipment and facility are executed as per the planner. Qualification of equipment and facility and area validation for GMP blocks as per schedule. Operations and maintenance of Utilities to enable operations Service contracts for equipment and Instruments are planned and executed. Ensure that team comprising of on-roll engineers and contract manpower are trained on GMP requirements. Evaluation, assessment and selection of vendors for providing services for maintenance, calibration and validation Overall maintenance management that includes handling unscheduled breakdowns and other general upkeep activities are as per requirement to enable operations. Identifying and maintaining Inventory of equipment spares required for maintaining continuous operations. Reviewing and analysing the energy and utility consumption like electricity units, water etc. and take measures for control. Implementing the energy saving initiatives. Facility design, detail engineering and execution of any new requirements for business growth. Preparing and presenting the MIS reports Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company procedures, internal and external customers with respect to quality, service, lead time and cost. Good exposure in Regulatory audit handling. Educational Qualification: BE/BTech in Mechanical or Electirical or Instrumentation. Technical/functional Skills Responsible for EAM activities in the Biologics Operations Unit Ensuring all assigned mandatory trainings related to data integrity, health and safety measures are completed on time. Develop and contribute to development of procedures, practices and setup that ensures safety operations compliant to company and regulatory norms. Leading engineering and maintenance team for GMP areas at Biologics Manufacturing and Biologics Process Development. Able to handle minor project, design review and execute and Facility modification in a GMP facility. Ensuring the related facility, equipment and maintenance systems are in GMP compliance state. Experience: 15 years or above within Biologics manufacturing plant, with at-least 6-7 years of experience in Leading Engineering team, Projects & Maintenance. Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

We use cookies to offer you the best possible website experience. Your cookie preferences will be stored in your browser’s local storage. This includes cookies necessary for the website's operation. Additionally, you can freely decide and change any time whether you accept cookies or choose to opt out of cookies to improve website's performance, as well as cookies used to display content tailored to your interests. Your experience of the site and the services we are able to offer may be impacted if you do not accept all cookies. Press Tab to Move to Skip to Content Link Skip to main content Home Page Home Page Life At YASH Core Values Careers Business Consulting Jobs Digital Jobs ERP IT Infrastructure Jobs Sales & Marketing Jobs Software Development Jobs Solution Architects Jobs Join Our Talent Community Social Media LinkedIn Twitter Instagram Facebook Search by Keyword Search by Location Home Page Home Page Life At YASH Core Values Careers Business Consulting Jobs Digital Jobs ERP IT Infrastructure Jobs Sales & Marketing Jobs Software Development Jobs Solution Architects Jobs Join Our Talent Community Social Media LinkedIn Twitter Instagram Facebook View Profile Employee Login Search by Keyword Search by Location Show More Options Loading... Requisition ID All Skills All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply now » Apply Now Start apply with LinkedIn Please wait... Lead - Process Excellence - Trackwise Job Date: Jun 7, 2025 Job Requisition Id: 61563 Location: Hyderabad, TG, IN Bangalore, KA, IN Indore, IN Hyderabad, IN Hyderabad, IN IN Indore, MP, IN, 452001 Pune, MH, IN Bangalore, KA, IN Gurgaon, IN IN Indore, MP, IN Indore, MP, IN Hyderabad, TG, IN, 500081 RJ, IN Hyderabad, TG, IN Indore, IN Noida, IN Pune, IN MY YASH Technologies is a leading technology integrator specializing in helping clients reimagine operating models, enhance competitiveness, optimize costs, foster exceptional stakeholder experiences, and drive business transformation. At YASH, we’re a cluster of the brightest stars working with cutting-edge technologies. Our purpose is anchored in a single truth – bringing real positive changes in an increasingly virtual world and it drives us beyond generational gaps and disruptions of the future. We are looking forward to hire Trackwise Professionals in the following areas : Job Summary: We are seeking a skilled and detail-oriented TrackWise Specialist to join our Quality Systems team. The ideal candidate will have hands-on experience with the TrackWise Quality Management System (QMS) and will be responsible for configuring, maintaining, and supporting TrackWise workflows and modules to ensure compliance with regulatory requirements and internal quality standards. Key Responsibilities: Configure and maintain TrackWise workflows, forms, and reports. Collaborate with cross-functional teams to gather requirements and implement QMS solutions. Perform system administration tasks including user access management, troubleshooting, and upgrades. Support validation activities including IQ/OQ/PQ documentation and execution. Provide training and support to end-users on TrackWise functionalities. Ensure compliance with FDA, ISO, and other regulatory standards. Participate in audits and inspections as a TrackWise subject matter expert (SME). Required Skills: 5+ years of experience working with TrackWise QMS (preferably versions 8 or higher). Strong understanding of quality processes such as CAPA, Deviations, Change Control, and Audits. Experience with system validation in a regulated environment (GxP, 21 CFR Part 11). Familiarity with SQL, Crystal Reports, or other reporting tools is a plus. Excellent problem-solving, communication, and documentation skills. At YASH, you are empowered to create a career that will take you to where you want to go while working in an inclusive team environment. We leverage career-oriented skilling models and optimize our collective intelligence aided with technology for continuous learning, unlearning, and relearning at a rapid pace and scale. Our Hyperlearning workplace is grounded upon four principles Flexible work arrangements, Free spirit, and emotional positivity Agile self-determination, trust, transparency, and open collaboration All Support needed for the realization of business goals, Stable employment with a great atmosphere and ethical corporate culture Apply now » Apply Now Start apply with LinkedIn Please wait... Find Similar Jobs: Careers Home View All Jobs Top Jobs Quick Links Blogs Events Webinars Media Contact Contact Us Copyright © 2020. YASH Technologies. All Rights Reserved.

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Junior Officer Date: Jul 4, 2025 Location: Ahmednagar - Engineering Company: Sun Pharmaceutical Industries Ltd Position: Jr Officer Engineering - Instrumentation Grade: G13 No. of Position: 1 No. Job Location: Ahmednagar Qualification: B.E. (Instrumentation) Experience: 4 to 5 yrs experience in Engineering (Instrumentation) of API manufacturing plant Job Profile Attending the breakdown related to process and utility equipment. Handle SAP activities, Calibration of manufacturing activities etc. Handle and monitor maintenance activities of process equipment and utility equipment such as PLC, HMI, SCADA and all automation systems. Handle QMS activities in Trackwise such as Change control, Deviations etc.in engineering department, to perform and support engineering related investigations. Co-ordinate and face the audits such as regulatory audit, statutory audits, safety audits etc. Handle SAP activities, Calibration of manufacturing activities etc. To attend the duties as per shift schedule. To take care of PCS related activities and to take care CSV Validation activities. Apply Now » Apply Now Start applying with LinkedIn Please wait...

Position: Jr Officer Engineering - Instrumentation Grade: G13 No. of Position: 1 No. Job Location: Ahmednagar Qualification: B.E. (Instrumentation) Experience: 4 to 5 yrs experience in Engineering (Instrumentation) of API manufacturing plant Job Profile Attending the breakdown related to process and utility equipment. Handle SAP activities, Calibration of manufacturing activities etc. Handle and monitor maintenance activities of process equipment and utility equipment such as PLC, HMI, SCADA and all automation systems. Handle QMS activities in Trackwise such as Change control, Deviations etc.in engineering department, to perform and support engineering related investigations. Co-ordinate and face the audits such as regulatory audit, statutory audits, safety audits etc. Handle SAP activities, Calibration of manufacturing activities etc. To attend the duties as per shift schedule . To take care of PCS related activities and to take care CSV Validation activities.

Title: Lead - Store & Warehousing Date: Jul 3, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd List of Responsibilities: R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have : ROLE PURPOSE: Candidate will be responsible for preparing and managing regulatory dossiers, coordinating with regulatory authorities for EU and ASEAN markets and providing guidance on regulatory requirements to internal teams. Skills Good communication skills (Written and Oral) MS Office (Excel and Power Point), Adobe Professional Desirable to have hands-on experience on RIMS preferably Veeva Vault, Trackwise PRINCIPAL RESPONSIBILITIES: Thorough knowledge of EU & ASEAN markets - country requirements/regulatory affairs procedures for initial submission, licensing, post-approval submission management Experience with global regulatory submission formats, including familiarity with submission publishing activities Organizes, leads, and facilitates and or participates in cross-functional meetings with stakeholders Understands the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across EU & ASEAN markets Leads and/or contributes to the planning, preparation (including authoring where relevant), and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective. Hands-on experience on regulatory document management systems and publishing tools Able to support and prepare Module 1 documents - submission form, cover letter, notification forms, comparison tables for regulatory submission Uses and shares best practices when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment Review the content prepared by junior team members. Validate the authenticity of the content by performing QC of the dossier prepared Coordinate with cross-functional teams, including R&D, quality assurance, and manufacturing, to gather necessary information and documentation for dossier preparation Tracks timely delivery of submission components, coordinates submission publishing activities with publishing team and organizes internal review and approvals. Tracking and maintaining the submission trackers Identifies regulatory risks and proposes mitigations to Lead and cross-functional teams Ensure submission/query/additional requests by HA should be communicated to the global colleagues through agreed process Able to extract regulatory intelligence information (requirements for CTA, drug/device/cosmetic/food registration etc.) Provides coaching, mentoring, and knowledge sharing within the regulatory organization Mentoring of new joiners with respect to SOPs and processes Exhibit flexibility in moving across new projects and preparation of multiple document types Continuously enhance and maintain knowledge of various writing guidelines for different deliverables by doing various assignments Understand various target audiences and methods to approach different deliverables Volunteer in training programs to develop skills in areas relevant to the job in addition to areas of interest EDUCATION: BPharm / MPharm/ Pharm D/ MSc Experience Required 4-6 years of experience in EU/ASEAN markets LOCATION: Bangalore, Hyderabad (Office-based/Hybrid) Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit, and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN

List Of Responsibilities R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

Department MORAIYA QC Job posted on Jul 03, 2025 Employment type P-P7-Probationer-HO Staff Role name: QC - QMS - GLP Division - Moraiya Department - Quality Control Category - Staff Qualification - M.Sc./B.Pharma/M.Pharma Experience - 4 - 5 Years Zydus Experience - Must have completed at least two PMS cycle. Job Responsibilities: Main activities- related to Trackwise - Change control/ CAPA /NQ incident trend / Risk assessment (rarely) / IRA documents submission like, raw data/chromatogram etc. , Effective ness check of CAPA in track wise / SOP revision and Training) 1. To ensure day-to-day monitoring and compliance of the laboratory activities. 2. To ensure data integrity and good laboratory practices in the department. 3. To ensure global CAPA implementation within timeframe. / To comply the statutory compliance aspect. 4. To follow the Good Laboratory Practices. 5. To maintain interpersonal relationship and provide support to other functional group in the department. 6. To maintain data integrity and follow cGMP and GDP. 7. To ensure that training is acquired for each activity/instrument prior to its execution/operation and that it is as per respective TNI. 8. To maintain and ensure controlled laboratory practice in the quality control department. 9. To ensure laboratory inventory management. 10. To follow the SOPs of Quality control department and related area. 11. To prepare / revise the SOP's, related to QC in software except microbiology lab. 12. To impart the training after revision of SOPs as per the requirement. 13. To perform related documentation/transaction in the software (e.g. LIMS, Zytims/Trackwise/SAP) based on assigned user privileges. 14. To assist in the Qualification / Installation of instrument equipment with suitable documentation. 15. To perform the qualification of instruments as per the requirements 16.To co-ordinate with in-house service engineers and / or external service engineers as and when required. 17. To participate and provide appropriate feedback during failure investigation (if any). 18. To review the raw data of Raw material / Finish product /stability sample/ Validation sample / Exhibit sample analysis with respect to SOP and GDP. 19.To ensure the destruction of remainant samples after analysis as per applicable procedure. 20. To ensure the usage of required PPE’s during respective activities in the laboratory. 21.To ensure up-keeping of the instrument/equipment. 22.To inform section head about any OOS/ OOC/Incident on its immediate occurrence and for day to day activities. 23.To investigate OOS/OOC/Incident (if any) under consultation with the department head/section head. 24.To keep the things and work area clean and tidy and get involved for the routine trouble shooting (if any). 25. To execute the activities with maximum output with complete documentation. 26. To provide documentation of commercial batches to IRA. 27. Responsible for implementing company quality ethics policy for data integrity and inform management and responsible data integrity compliance head on any data integrity issues as per corporate data governance policy. 28. To prepare the audit response of internal/external customer/SME observation to QC. 29. To perform related documentation/transaction in the software (e.g. LIMS, SAP, Trackwise, DMS, Minitab, Zytims, Legatrix) based on assigned user privilege. 30. To initiate, track and closure of QMS event (CAPA, change control, incident, deviation, event, extensions etc, through Trackwise and in format-based system) and escalate it for completion. 31. Handling of laboratory information Management System (LIMS) system under the guidance of LIMS administrator, which includes preparation/modification/review and approval of specifications, worksheets, tests plans, stability protocols, Masters etc. as per requirement. 32. To assist Validation/Re-validation of LIMS modules as and when required. 33. To prepare validation protocol and report and co-ordinate for the validation of spread sheets as and when required. 34. Completion of Any other specific work or assignment as given by the section head/department head. 35. To report abnormalities (if any) to section head or designee. 33. To prepare Quality metrics and QI sheet, department level QRM data and to record action plan 34. To prepare trend data of QMS events. 35. To prepare analytical method verification/validation protocol/report. 36. To initiate the activity regarding New / revision of technical agreement / Quality agreement. 37. To initiate the Risk assessment / Gap assessment involving in the respective activity 38. To Make entry and verify the details in Zytimes. 39. To perform the required activities related to QUEST / SLIM programme. 40. To perform the required activities related to statutory requirements in Legatrix. 41. Management of column and other resources used in analytical activities. 42. To escalate the Issues related to the Process, Product, Quality, Cleaning process or documentation related activities to his/her immediate supervisor and take the appropriate action related to it. 43. To escalate any failures and overdue activity that can have a potential impact on product quality to his/her immediate reporting authority.

Job Title: QA Sr. Executive – Pharmaceutical Manufacturing Department: Quality Assurance Reports To: QA Manager Location: Ahmedabad Employment Type: Full-Time Job Summary: The QA Executive plays a critical role in ensuring that all pharmaceutical products are manufactured in compliance with cGMP guidelines, regulatory requirements, and internal quality standards. The role involves overseeing production processes, documentation, audits, deviation handling, and supporting continuous quality improvements to ensure patient safety and product efficacy. Key Responsibilities: Ensure compliance with GMP (Good Manufacturing Practices) and applicable regulatory requirements (e.g., USFDA, MHRA, WHO, EU, TGA ). Review and approve manufacturing and packaging batch records, logbooks, and equipment qualification protocols. Monitor production and quality control activities to ensure alignment with SOPs and regulatory standards. Execution of Qualification / Validation Activity and Documentation. Conduct line clearance , in-process quality checks, and batch release documentation. Manage and investigate deviations, change controls, CAPA, OOS, and OOT cases. Participate in internal audits and support regulatory inspections by preparing documentation and responding to queries. Maintain QA-related documentation including SOPs, quality manuals, and validation reports . Review and approve Standard Operating Procedures (SOPs) and ensure their periodic revision and compliance. Participate in vendor audits and qualification processes for raw materials and packaging materials. Train staff on quality procedures, GMP guidelines, and hygiene practices. Required Qualifications: Master’s degree in Pharmacy ( M.Pharm - QA) or related life sciences. Sound knowledge of GMP, ICH guidelines, regulatory compliance , and pharmaceutical documentation. Familiarity with QMS systems and electronic documentation tools (e.g., TrackWise, Master Control). Good understanding of equipment validation, cleaning validation, and process validation principles. Key Skills: Strong analytical and documentation skills Attention to detail and accuracy Effective communication and teamwork Problem-solving and root cause analysis Knowledge of regulatory inspection protocols

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Lead - Store & Warehousing Date: Jul 3, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd List Of Responsibilities: R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security. Apply Now » Apply Now Start applying with LinkedIn Please wait...

At EY, you’ll have the chance to build a career as unique as you are, with the global scale, support, inclusive culture and technology to become the best version of you. And we’re counting on your unique voice and perspective to help EY become even better, too. Join us and build an exceptional experience for yourself, and a better working world for all. EY- GDS Consulting – Enterprise Risk (ER) – Regulatory Compliance –LIMS Consultant - Senior As part of our EY-ER- Regulatory Compliance team, you will help the clients by understanding their business needs and delivering solutions in accordance with the EY guidelines & methodologies. As a Regulatory Compliance senior actively establish, maintain and strengthen internal and external relationships. In line with our commitment to quality, you’ll consistently drive projects to completion with high quality deliverables, achieve operational efficiency, proactively identify and raise risks with the client as well as EY senior management team and lead internal initiatives. The opportunity We’re looking for Senior with expertise in LIMS Implementations & Configurations for Life Sciences industries to join our EY-Regulatory Compliance team. This is a fantastic opportunity to be part of a leading firm whilst being instrumental in the growth of emerging service offering. Your Key Responsibilities Work closely with business stakeholders, laboratory personnel, and IT teams to gather and document LIMS requirements. Gather and analyse business requirements related to LIMS functionality and enhancements. Analyse laboratory workflows and processes to recommend and implement LIMS solutions. Translate business needs into functional specifications and system configurations. Configure, test, and validate LIMS functionalities to meet business needs. Conduct impact analysis and risk assessments for LIMS changes and enhancements. Serve as a liaison between business users and technical teams to ensure effective communication and system alignment. Participate in business process mapping and workflow optimization to enhance LIMS utilization. Provide input on LIMS enhancements and new feature development to improve system performance. Assist in troubleshooting, identifying, and resolving LIMS-related issues. Conduct user training sessions and provide end-user support. Work with laboratory teams to ensure LIMS supports laboratory practices, procedures, and workflows effectively. Identify opportunities for automation and process improvement within laboratory operations using LIMS. Master Data Design Configuration Analyse the Technical documents such as SOP/STP/Monograms/Pharmacopeial references and convert them into LIMS compatible data sets. Configure master data elements such as test methods, sample types, specifications, workflows, and stability studies within LIMS. Maintain data integrity, consistency, and version control across the system. Implement changes and updates to LIMS master data in alignment with business and regulatory needs. Collaborate with cross-functional teams to ensure accurate data migration and system integration. Troubleshoot and resolve issues related to master data configuration and system functionality. Work on optimizing data structures and database management within LIMS. Configurations & Customizations Develop, customize, and implement LIMS applications to meet laboratory and business requirements. Configure, extend, and support LabWare LIMS, LabVantage LIMS, and other LIMS platforms. Integrate LIMS with other enterprise systems such as ERP, ELN, CDS, MES, and laboratory instrumentation software. Design and optimize databases for efficient storage and retrieval of laboratory data. Develop and maintain system interfaces, workflows, and automation scripts to streamline laboratory processes. Provide technical support, troubleshooting, and bug fixes for LIMS applications, ensuring minimal downtime. Collaborate with laboratory personnel, IT teams, and stakeholders to enhance system functionality and usability. Create and maintain system documentation, including user guides, SOPs, validation protocols, and technical specifications. Ensure compliance with industry standards such as CGxP, PICS, FDA 21 CFR Part 11, EU GMP Annex 11 etc. Stay up to date with new LIMS technologies, trends, and best practices. Ensure system security, access control, and compliance with IT policies. Provide ongoing support and maintenance for LIMS applications. Engage in change management processes and drive adoption of new system functionalities. Work with vendors and third-party providers to Configure, implement upgrades and enhancements. Demonstrate teamwork by working with cross functional teams across service lines in completing the deliverables within the timelines Maintain a strong client focus by effectively serving client needs and developing productive working relationships with client personnel. Stay abreast of current business and economic developments and new pronouncements/standards relevant to the client's business. Review status updates and prepare management presentations. Actively contribute to improving operational efficiency on projects & internal initiatives. Demonstrate a detailed knowledge of market trends, competitor activities, EY products and service lines. Contribute to performance feedback for staff Foster teamwork and a positive learning culture Understand and follow workplace policies and procedures Training and mentoring of project resources Cross skill and cross train the team members as per the business requirements Skills And Attributes For Success Strong understanding of laboratory workflows, sample lifecycle management, and data integrity principles. Familiarity with analytical techniques, laboratory instrumentation, and regulatory standards. Exposure to Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and ISO 17025 compliance. Experience in working with scientific and analytical teams to align LIMS functionality with laboratory operations. Understanding of quality control, stability studies, environmental monitoring, and batch release processes within laboratories. Proficiency in LIMS software (e.g., LabWare, LabVantage, STARLIMS, SampleManager, or similar platforms). Knowledge of system integration with ERP, MES, or other enterprise applications. Previous experience as a Business Analyst or System Administrator or Master Data Manager working with LIMS. Hands-on experience in master data configuration within LIMS platforms. Experience in system validation, testing, and documentation. Exposure to Enterprise IT applications like ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, etc. in Pharmaceutical organization Understanding of relational databases and SQL queries. Experience with scripting or automation tools for LIMS is a plus. Understanding of API integrations, web services, and middleware solutions for LIMS. Ability to troubleshoot system and data issues efficiently. Strong problem-solving and analytical skills. Excellent communication and stakeholder management abilities. Ability to work independently and as part of a cross-functional team. Strong attention to detail and commitment to data integrity. Adaptability to dynamic business and regulatory environments. Demonstrated track record in project management, governance, and reporting Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management. Prior experience of supporting Audits / Inspections To qualify for the role, you must have B.E/B.Tech (Comp. Science/ Life Sciences/Chemistry/Information Technology or a related field)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 4-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies or Leading Life sciences / Pharmaceutical Industries. Good interpersonal skills; Good written, oral and presentation skills Ideally, you’ll also have Information Security (ISO 27001) or Risk Management certifications LIMS admin certification or Equivalent Certified Scrum Master (CSM) or Equivalent (Preferred but not required). What We Look For A Team of people with commercial acumen, technical experience and enthusiasm to learn new things in this fast-moving environment with consulting skills. An opportunity to be a part of market-leading, multi-disciplinary team of 1400 + professionals, in the only integrated global transaction business worldwide. Opportunities to work with EY Consulting practices globally with leading businesses across a range of industries What Working At EY Offers At EY, we’re dedicated to helping our clients, from start–ups to Fortune 500 companies — and the work we do with them is as varied as they are. You get to work with inspiring and meaningful projects. Our focus is education and coaching alongside practical experience to ensure your personal development. We value our employees and you will be able to control your own development with an individual progression plan. You will quickly grow into a responsible role with challenging and stimulating assignments. Moreover, you will be part of an interdisciplinary environment that emphasizes high quality and knowledge exchange. Plus, we offer: Support, coaching and feedback from some of the most engaging colleagues around Opportunities to develop new skills and progress your career The freedom and flexibility to handle your role in a way that’s right for you EY | Building a better working world EY exists to build a better working world, helping to create long-term value for clients, people and society and build trust in the capital markets. Enabled by data and technology, diverse EY teams in over 150 countries provide trust through assurance and help clients grow, transform and operate. Working across assurance, consulting, law, strategy, tax and transactions, EY teams ask better questions to find new answers for the complex issues facing our world today.

NAB is looking for Analyst to join our dynamic team and embark on a rewarding career journeyGather, analyze, and interpret complex datasets to identify trends, patterns, and insights that support strategic decision-making within the organization.Develop, maintain, and update detailed reports, dashboards, and visualizations to communicate key metrics and findings to stakeholders.Collaborate with cross-functional teams to understand business needs, translating them into data requirements and actionable insights.Conduct market research, competitor analysis, and customer behavior studies to inform business strategies and improve performance.Monitor data integrity and accuracy, implementing quality control measures to ensure reliable, consistent reporting.

Hands-on experience on testing tools like HP ALM, Kneat and SNOW - Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of understanding - OT Security will be a plus. - Standalone Systems Qualifications - PAS/DCS Integrated with Manufacturing Equipment qualification. Key components of the responsibilities are as mentioned below but not limited to:  6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry.  Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.  Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.  Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.  Stakeholder management and good executor with required communication.  Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test Management & Compliance  Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.  Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc.

Position: Sr Software Eng Supervisor The purpose of Sr Software Eng Supervisor role is to ensure robust product quality in collaboration with Honeywell technology and business stakeholders. The role demonstrates leadership across multiple product subsystems and is responsible to spearhead the development and implementation of comprehensive Test strategy along with automation and simulation strategy across the Life Sciences portfolio. Education: B.E. (Bachelor of Engineering) and B.Tech. (Bachelor of Technology) – Instrumentation and Control, Electrical, Electronics or Equivalent. Experience: Extensive experience (16+ Years) in Batch, Life Sciences, Pharmaceutical domain / verticals and strong experience in Manufacturing Execution System (MES) and Distributed Control Systems (DCS). Desired Skills This leadership role is responsible for providing best quality test deliverables; demonstrating test ownership; aligning test resources and driving test execution and performance to meet customer requirements; developing our test resources and capabilities; and driving standard work of the test methodology, equipment, process, and practices. This leadership role will manage/oversee the day-to-day test operations of multiple test teams. This role requires close coordination of with cross LOB Test and development leads. At Honeywell, our people leaders play a critical role in developing and supporting our employees to help them perform at their best and drive change across the company. Help to build a strong, diverse team by recruiting talent, identifying and developing successors, driving retention and engagement, and fostering an inclusive culture. Hands on/In depth understanding of Distributed Control Systems for Batch, Life Sciences and Pharma Industries. Domain understanding of DCS system deployment in Pharma, Batch or F&B verticals, having working experience of Manufacturing Execution System (MES) and Control Systems for Batch process. Candidate is required to have Strong Domain Knowledge on Pharma/Drug Manufacturing Sector , the Compliance/Regulatory requirements of the Pharma Sector . Candidate should have a strong understanding of ISA S88 , ISA S95 , FDA , GMP and cGMP Standards and guidelines. It will be preferred if the Candidate also has a strong process and Operations knowledge/Experience in Batch Processing Industries like Pharma, Spec Chem, Food & Beverages. Hands-on work experience with top Life Sciences, Pharma, Biopharma, CDMO, API, Nutraceuticals, Cosmeceuticals, Food Processing, Cell & Gene Therapy manufacturing companies. The Candidate should have experience in Project Engineering, Commissioning and Maintenance of Pharma/Batch Projects with some of following systems e.g. Honeywell Experion Batch Manager , Total Plant Batch , etc . The Candidate should have experience in Engineering, Operation and Maintenance of Pharma/Batch MES Manufacturing Execution System platforms and modules like MBR, EBR, W&D, Elogs and interfaces to L3/L4 Systems like ERP, QMS, DMS, TMS, LIMS, etc Working experience deploying or operating MES at Pharma companies. Should have had experience in Batch Design – Process and Equipment Model based on the Process and Design Inputs. He/She must have experience of FAT/SAT of Batch Projects. Good knowledge on cGMP documentation. Knowledge on Digital platform SAP & TrackWise to handle PM/BD and QMS documents. Should have working knowledge on Batch sequence programming using ladder programming, FBD, SFC and other languages described in IEC61131-3 standard. Should have sound knowledge of different communication protocols for third party interfaces and for field device integration. SDLC process and various Test management tools and Processes. Virtualization concepts and deployment understanding. Proven track record of managing complex programs successfully which have critical business knowledge and skills Candidate should be able to support, lead and influence team to drive changes successfully Understanding of various testing and development methodologies, Test Automation using Selenium, Python, JMeter, Test Complete, etc and DOE (Design of Experiments) techniques to optimize efforts Strong communication and Interpersonal skills and should have worked extensively with global stakeholders like projects, TAC, services etc Hands on knowledge on breadth of product including various communications standards, controllers, interfaces, Knowledge of Honeywell systems, various performance and capacity specifications etc. Continuous improvement and Innovative mindset is essential and candidate should have created/implemented new ideas Uses strong domain and product knowledge to guide team to ensure completeness of deployment scenarios, use cases and user profile and built-in product quality. Responsible for product validation strategy including estimation, new methodologies, DOE, architecture risks mitigation during elaboration, automation and simulation planning.

We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future-ready. We offer accelerated, global growth opportunities for talent thats bold, industrious, and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship and is guided by passion, innovation, collaboration, and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out www.careers.indegene.com. Looking to jump-start your career? We understand how important the first few years of your career are, which create the foundation of your entire professional journey. At Indegene, we promise you a differentiated career experience. You will not only work at the exciting intersection of healthcare and technology but also will be mentored by some of the most brilliant minds in the industry. We are offering a global fast-track career where you can grow along with Indegenes high-speed growth. We are purpose-driven. We enable healthcare organizations to be future ready and our customer obsession is our driving force. We ensure that our customers achieve what they truly want. We are bold in our actions, nimble in our decision-making, and industrious in the way we work. Must Have Responsibilities The Regulatory Lead role is responsible for managing regulatory operations including initial submissions and life cycle management of products, ensuring regulatory compliance in all marketed regions. This includes: Planning and execution of new product registrations, line extensions, new indications, license renewals, variations management, and label updates throughout the life cycle of a marketed product ensuring compliance with local regulations and quality system requirements. Preparing, reviewing, and submitting regulatory dossiers for marketing authorization (MA) applications, ensuring timely and high-quality submissions in compliance with Health Authority regulations including but not limited to US, CA, EU, LATAM, APAC, GCC, and CIS countries. Managing post-approval activities, preparing and submitting applications for registration and import licenses, renewals, variations and ensuring compliance and timely renewals of regulatory commitments, while working with the client, and their local affiliates as applicable. Building and leading an excellence-focused team ensuring key operational metrics and compliance standards, maintaining high levels of accuracy and efficiency. Facilitating and cultivating relationships with local Regulatory Agencies/affiliates and Health Authorities to achieve successful outcomes and strategic alignment for submissions and schedules in each country. Ensuring Regulatory submissions and subsequent HA communication/responses within planned timelines. Voicing affiliate perspectives and needs to global and regional regulatory contacts. Maintaining regulatory tools in alignment with defined compliance metrics. Staying aware of current regulations and anticipating the implications and opportunities of changes in the regulatory environment. Communicating changes to appropriate management and cross-functional experts and implementing them locally. Addressing complex regulatory and business challenges, collaborating across functions and regions to drive favorable outcomes and acting as a subject matter expert, assisting team members with troubleshooting and presenting solutions to project-related problems. Assessing change control issued by quality or regulatory departments, evaluating regulatory impact, and developing submission strategies. Ensuring accurate documentation and management of regulatory activities and data, maintaining and updating local Regulatory Affairs SOPs in adherence to quality standards. Leading meetings with clients to discuss proposals, project status, and general business development activities. Developing and implementing long-term regulatory optimization and streamlining initiatives to enhance compliance and business efficiency. Requirements: BPharm, MPharm, Pharm D, or MSc. 8-10 years in Regulatory Affairs and Submissions Management. Experience with life-cycle management activities (e.g. Europe, USA, International would be an asset). In-depth knowledge in Regulatory Affairs and experience of working in a global regulatory environment including exposure to registration procedures (EU - CP, MRP, DCP, National etc.) and LCM strategies. Familiarity with Veeva RIMS, TrackWise, and other RIMS systems. Strong project management and documentation skills, proactive communication approach. Great customer service skills, able to work well and manage a team. Advanced skills in Microsoft Office and Adobe Professional. Good to have EQUAL OPPORTUNITY Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, the candidates merit and qualification. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Locations Bangalore, KA, IN

The Supply Operation Quality (SOQ) Senior Associate will be responsible for supporting, maintaining, and implementing the Quality Management System (QMS) at the Pfizer Country Offices (PCOs) to ensure compliance with both Pfizer and Regulatory Authority expectations. The SOQ Senior Associate will work closely with relevant local stakeholders, such as Global Regulatory Sciences (GRS), Global Supply Chain (GSC), Medical, and PGS sites or ESOQ to ensure that the appropriate quality standards and systems are implemented and maintained for the product supply operation of the Pfizer India and neighboring market (Sri Lanka, Bangladesh, Nepal) business. Quality Assurance & Inspections and Internal Audit Assists with the timely implementation of applicable quality management systems (SOPs) within the PCO. Assists with ensuring initial and continuous training programs are implemented and maintained for all relevant PCO colleagues. Ensures planned, permanent & temporary changes of GMP/GDP related activities & systems are managed & documented appropriately. Ensures change actions are completed as per agreed timelines. Collects key quality performance indicators, evaluates and highlights any significant trends and identifies actions. Monitor Key Performance Indicators (KPIs) of the QMS, evaluate and highlight significant trends, and identify actions. Leads and/or participates in Quality Review Meetings as required. Provides support in the preparation and coordination of any Health Authority (HA) inspection and/or internal Pfizer audits of GMP/GDP activities in the PCO. Work with local cross functional team to define appropriate action plans to address the inspection/audit observation and tracks action implementation within the agreed timelines. Participates in the self-inspection program as an auditor and/or auditee, as required. Leads and/or participates in the Quality Risk Management program for the consistent application, documentation and communication of risks to product quality/patient safety in support of GxP activities under the remit of SOQ. Local Product Disposition & Resolution of Product Quality Perform the local release process of Products under the PCOs distribution license, as required. Supports the coordination of all Product repackaging and/or relabelling activities in the PCO and at the third-party packaging site. Review and approve documentation related to the repackaging and/or relabelling of Pfizer Product, as required. Actions Quarantine Alert Notifications promptly, as needed. Ensures quarantine shipments are managed compliantly according to procedures, as required. Provides support for any market action operation in the PCO, as required. Complaint Handling – Perform Intake and Triage, issue correspondence letter as required. Acts as a contact point for Regulatory Agency/reporter in the PCO, as required. Lead and/or participate in deviation investigations using appropriate tools and works with cross-functional teams to implement CAPAs. Notify Management of significant concerns or deviations within the QMS which have the potential to impact product, regardless of release status. Where issues originate in the PCO, assist with the preparation of QRT meetings, where required. Assist with the implementation of local actions identified during QRT. Management of relevant corrective and preventative actions (CAPA) Supplier Quality Management Execute tasks associated with the management of GxP Suppliers including qualification, quality oversight in accordance with internal and regulatory requirements for GxP activities. Assists with ensuring appropriate customer screening processes are in place to align with Pfizer and local regulations, as required. Assist with the coordination of RQA audits at the Supplier. Leadership Skills Facilitate development and execution of objectives / projects consistent with SOQ Purpose Blueprint. Development and Maintenance of Quality culture, within the team and organisation. Qualifications A minimum Tertiary Education in Science, Pharmacy or related discipline A minimum of 5 years in the pharmaceutical industry in a quality role Fluent in English (written and verbal) Experience in Quality administered systems. Excellent computer system skills – Word and Excel essential. Experience with electronic documentation control systems advantageous. Demonstrated ability to influence, when necessary, particularly with stakeholders and external parties. Experience in GMP, GDP and QMS. Technical writing and reporting Previoususe of Trackwise®, eQMS beneficial. Competencies Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy. GMP/GDP Knowledge. Trained and experienced in the total application of GMP/GDP. Auditing. Knowledge of Auditing procedures. Technical writing. Ability to lead a technical investigation and report to all levels of oganisation. Ability to write well-structured technical reports. Problem solving. Ability to use problem solving skills and tools to identify and eliminate problems as they arise. Takes initiative and ownership to deliver on time without compromising on quality. Ability to communicate effectively verbally and in writing, good negotiation and influencing skills. Acts Decisively. Makes decisions in a timely manner, makes good decisions based upon a mixture of analysis, experience, and judgment. Able to demonstrate good planning and organisation. Dealing with Ambiguity. Can effectively cope with change and handle risk and uncertainty. Emotional Intelligence. Identify, assess and control the emotions of oneself and awareness of others. Takes Responsibility. Takes personal ownership of responsibilities and outcomes while following through on commitments Work Location Assignment: Hybrid Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Quality Assurance and Control

Educational Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Service Line Application Development and Maintenance Responsibilities Key components of the responsibilities are as mentioned below but not limited to:6+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Leads the effort to manage, and/or maintains validation of the GxP computerized systems. Create Validation Plan, Validation Report and Reviews validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ’s, TRM.Assure compliance with GxP (GMP, GCP, GLP) & privacy requirements. Develops and maintains IT GxP compliance documentation.Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.Stakeholder management and good executor with required communication.Candidate must have fair conceptual understanding on below key areasoIT QMSoValidation/QualificationoRisk management. oHandling of defects/Deviations oInvestigations oCAPA Handling oTest Management & Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide.Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Technical and Professional : Hands-on experience on testing tools like HP ALM, Kneat and SNOW-Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage -OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus)-PAS/DCS Qualification -ISA95 High level of understanding -OT Security will be a plus.-Standalone Systems Qualifications-PAS/DCS Integrated with Manufacturing Equipment qualification. Preferred Skills: LS Domain-Computer System Validation (CSV)

As a Fortune 50 company with more than 400,000 team members worldwide, Target is an iconic brand and one of America's leading retailers. Joining Target means promoting a culture of mutual care and respect and striving to make the most meaningful and positive impact. Becoming a Target team member means joining a community that values different voices and lifts each other up . Here, we believe your unique perspective is important, and you'll build relationships by being authentic and respectful. Overview about TII At Target, we have a timeless purpose and a proven strategy. And that hasnt happened by accident. Some of the best minds from different backgrounds come together at Target to redefine retail in an inclusive learning environment that values people and delivers world-class outcomes. That winning formula is especially apparent in Bengaluru, where Target in India operates as a fully integrated part of Targets global team and has more than 4,000 team members supporting the companys global strategy and operations. A role in Finance Ops calls on your skills for quality financial and inventory reporting and accurate financials and technical accounting while providing thoughtful and responsive support, expertise and guidance to business partners. Your role will be critical to ensuring the success of Targets business initiatives and core retail operations. As a Sr. Specialist, Merch Payables, you will be responsible for reconciling store/DC invoices for prompt and accurate payment. This individual will provide extraordinary customer service to vendors and merchants by researching, resolving, and negotiating disputes relating to deductions from invoice payments in a thorough and timely manner, while ensuring protection of company assets. Additionally, you will be responsible for Invoice Reconciliation - Identifies opportunities to improve payment process. Maintains organized correspondence file of incoming, in research, and resolved disputes. Maintains working knowledge of distribution, inventory, purchase order, markdown, unit information, transportation and accounts payable systems. Vendor Relations - Provides extraordinary customer service to vendors and merchants by resolving disputes. Researches all items disputed relating to deduction for shortage, cost differences, markdown allowance reversals, return discrepancies, accounts payable violations, terms/discounts and other miscellaneous vendor issues to establish their validity. Coordinates research with the Merchants, Vendor Relations and Transportation to establish validity of deductions. Productive Partnerships - Proactive in developing productive partnerships with Merchandising, vendors and other areas of Target. Learns and understands the process and business of our customers. Process ImprovementIdentifies invoice and purchase order issues which cause reoccurring processing problems and disputed deductions, including special focus on Individual Performance Vendors (IPV). Work with supervisor to challenge status quo to resolve these continuing problems. Contact the responsible parties to correct the issue, and follow up to ensure the correction was implemented. Facilitates Communication - Maintains an excellent level of verbal and written communication between vendors and other areas of Target. Initiates, coordinates and leads meetings between teams, Merchandising, vendors and/or other areas of Target. Team and A/P Accountability - Operates in a team structured environment assisting with training and sharing expertise and information. Works with other team members and takes responsibility for covering for any or all in your business group. Participates in developing, implementing and achieving objectives/goals with the Team Lead and Supervisor that are consistent with team, department and A/P. Special Projects - Coordinates and/or participates in special projects as directed by SME, Analyst or Manager. Core responsibilities are described within this job description. Job duties may change at any time due to business needs . About you: Four-year degree or equivalent experience 1+ years of previous accounting or accounts payableexperience Strong interpersonal and communication skills (verbal and written) Excellent negotiation, organizational and problem solving skills Experience with Word, Excel, Access knowledge Strong teamwork and conflict resolution skills

Be the First to Apply Job Description Job Overview Provides first line supervision of the plant and is fully competent on all relevant operation, start-up, cleaning and checking procedures associated with the operation of at least one plant, ensuring a high quality output is achieved in a safe and effective manner. This includes monitoring and controlling the work activities of the team in a given area of plant and escalating issues effectively to Team leader or Managment Expert in Group 1 process, at least three Group 2 and Group 3 processes in core area of work. Subject matter expert supporting and leading RCF and CANDO activities in conjunction with Team Leader. Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader. Flexibility to work across API Plants as required to support to the business. Competencies Investigates and reports problems on equipment and organises maintenance through direct interaction with engineers, and through escalation to Team leader or directly to management Competent to write permits and carry out risk assessments up to Hot work permit. Understands RCF investigation process and can lead thorough and timely investigation into any incident or issue on shift. Accurately documents issues on Batch documentation and can add accurate and detailed SI comments as required Understands their training targets and responsibilities and is proactively working with TL in execution of their training plan. Supports training plan of team members in their area through coaching, training and supervision of processing activities of trainees Has a high awareness of Safety and of the identified hazards in the API facility. Is able to identify safety critical issues and understands the correct actions to rectify or escalate as appropriate. Coaches and works with team in their area to build their skills in hazard identification. Leads CANDO activity in their area and monitors housekeeping and plant standards in their area of operation ensuring operation is at standard at all times. Key Responsibilities Fully competent in the completion and review of all batch related documentation, equipment / area log books, and computer transactions associated with the process. Will monitor and record all actions to the highest DI standards Responsible for the quality of work as all work is subject to GMP Issuance of permits up to hot work level Supervision of plant in absence of team leader (Trained in Ensur, Workmate, Trackwise, SAP and Open Options. Capable of seamlessly covering for Team Leader). First point of contact for operators on all production matters. Raises REW’s and DR’s as required. Progresses SOP / SOI updates Takes on a key role in new product introduction, liasing with other departments and getting involved at early stage of process. Works under some direct supervision but takes ownership and escalates issues if support is required Will manufacture a wide variety of products according to SOP’s Fully competent in the operation of at least one plant, and have significant knowledge of operations in at least one other. Selects and dispenses required material, loads equipment, making adjustments to process as necessary May carry out minor maintenance work to minimise down time, e.g., tighten flanges, change pressure gauges, replace pH probes, etc. This must be done fully following permit or written risk assessment and ensuring all procedures are followed. Required to clean and wash equipment following established procedures Leads and drives improvements with measurable benefits Investigates and reports problems on equipment and organises maintenance. Has responsibility for production and all associated paperwork and computer data entry Demonstrates leadership skills Qualifications Essential Qualifications Able to coach and train operators in process operations Wide and deep experience of API operations and of plant systems. Expert in API processing in their area of operation. Able to investigate and document any process, Quality, or ESH issue identified in their area. Understands and is competent in RCF methodologies. Relevant Experience Possesses practical knowledge of the process; which allows for effective problem resolution of production issues. About Us In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices. Equal employment opportunity Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics. We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice. About The Team Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide. Job Info Job Identification 9000 Job Category API Production Posting Date 06/26/2025, 12:59 PM Job Schedule Full time Locations Whalton Road, Morpeth, Morpeth, United Kingdom (County Level), NE61 3YA, GB

Company Description Syner-G BioPharma Group is a science-led, strategic partner for life science companies. We provide integrated regulatory and biopharmaceutical development services spanning early development to post-market, along with operational strategy and support. With a global team of 400 employees across North America and India, our goal is to help our partners navigate the complexities of product development and accelerate their journey to market. We are a leading life sciences consultancy committed to advancing human health by helping organizations bring life-saving innovations to market faster, at scale, and with the highest quality. Our team partners with a diverse range of clients across the life sciences industry, supporting critical phases of the drug development lifecycle, from discovery and regulatory approval to technology transfer and the support in capital projects. We provide strategic guidance and hands-on expertise to streamline operations, enhance quality systems, and ensure regulatory compliance, empowering our clients to navigate complexity and deliver impactful therapies to patients worldwide. Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership, and innovation. At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. For more information, visit www.Synergbiopharma.com Position Overview Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in the area of Chemistry, Manufacturing, and Controls (CMC), with a focus on post-approval regulatory submissions. This remote role, based in Bangalore, Chennai, Hyderabad, or Mumbai, involves providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements. The ideal candidate will bring strong scientific acumen, regulatory expertise, and leadership capabilities. Key Responsibilities (This list is not exhaustive and may be supplemented or changed as necessary.) Lead and manage regulatory milestones for assigned products throughout the product lifecycle Contribute to strategic regulatory discussions and decision-making processes Develop and execute CMC regulatory strategies for post-approval pharmaceutical products in compliance with US, EMA, and global regulations Author and review global CMC submissions and supporting documentation for post-approval supplements, variations, and responses to health authority queries Collaborate with internal teams and external partners to ensure compliant execution of change management activities Coordinate timely and accurate responses to regulatory authority questions (RTQs) related to CMC content Manage regulatory operational activities including organizing, tracking, and preparing submissions for publishing Conduct regulatory change control assessments and strategize post-approval implementation and reporting Review technical documents such as certificates of analysis, analytical methods, specifications, and stability data Prepare and support CMC documentation for post-approval submissions, new market registrations, and source of supply changes Maintain up-to-date knowledge of FDA, EU, and global regulations and guidance relevant to marketed products Identify and communicate potential regulatory risks and mitigation strategies Lead or support a team of 2 to 4 regulatory professionals, providing guidance and oversight on project execution Potentially contribute to pre-approval submissions (IND/CTA/IMPD) depending on experience Education QUALIFICATIONS AND REQUIREMENTS: Bachelor’s or Master’s degree in Pharmacy, Biological Sciences, Engineering, or a related field. Advanced degree preferred Experience Minimum 7 years of experience in CMC post-approval regulatory submissions or related fields such as manufacturing, quality control, or analytical development At least 5 years of experience authoring and reviewing CMC sections in Modules 1, 2, and 3 for post-approval filings Strong knowledge of US and European regulatory frameworks and ICH guidelines Experience in pharmaceutical development, drug product specifications, and stability programs Familiarity with cGMP environments and regulatory systems/tools (e.g., EDMS, Veeva Vault, Trackwise) is a plus Prior supervisory or team leadership experience is preferred Skills And Attributes Excellent written and verbal communication skills Strong organizational and project management abilities Ability to manage multiple priorities and work independently in a fast-paced environment Proactive, detail-oriented, and self-motivated with a strong work ethic Work Location: Remote position based in Bangalore, Chennai, Hyderabad, or Mumbai, with pan-India operations. Legal Statement Syner-G BioPharma Group is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.

Title: Lead - Store & Warehousing Date: Jun 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Lead Stores & Warehouse of R&D Baroda R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security.

Search by Keyword Search by Location Show More Options Loading... Location All Select How Often (in Days) To Receive An Alert: Create Alert Select How Often (in Days) To Receive An Alert: Apply Now » Apply Now Start applying with LinkedIn Please wait... Title: Lead - Store & Warehousing Date: Jun 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Lead Stores & Warehouse of R&D Baroda R&D Baroda Stores – Overall upkeep & management Monitor Bills processing – in time GRN processing after users’ acceptance / bill submission to SSC. Monitor material inward - receipt, delivery – Normal / Temperature controlled condition / Imported material. Monitor material outward - International & Domestic samples despatch under normal / temperature-controlled condition as per approved ARC / Rates through approved Couriers after proper evaluation of rates & Service take care of Export documentation in co-ordination with Courier, Users. Monitor Inventory management of stores-controlled lab chemicals /Commercial Solvents / Gen. Lab consumables /Housekeeping /Stationery items. Monitor manpower utilization - OT Control Monitor Stores upkeep. Monitor mailing activities - Inward / outward Monitor FRD WH area– API / Excipient stock management through Bin Card / WH upkeep. Communication to Users / HODs about procedural changes / Regulatory Updates / providing Consumption data of Stores-controlled lab-chemicals, solvents, etc. R & D Stores - documenting as per GST Rules Ensure R & D material movement document process as per GST Rules – STO generation / Invoicing through SAP system / E-way bill generation / Proper transaction closure by accounting document / cancellation of open STOs / non-dispatch invoices / return of rejected material by getting Credit notes from Vendors Monitor Asset movement with proper documentation – DRT approval / invoicing with proper material codes / follow insurance process. Monitor scrap sale transactions as per defined process with proper documentation – Invoicing under proper scrap codes as per ARC Monitor Returnable Material movement – process through Electronic Gate Pass System – Overall control – ensure timely closure. Monitor submitting of GST related reports on monthly basis to IDT Team in time. Regulatory compliance Regulatory compliances under Prohi. & Excise related licenses-DD1/DD3/RS2/MA1/AC2 as per respy. License requirement - Monitoring receipt / Storage / Issuance / stock keeping as per limit / documentation /stock register maintenance /License Renewal /Product addition under DD1/DD3 / Record keeping as per License requirement. Getting APP from IC, Gandhinagar for additional Alcohol requirement & get it approved under RS-2 License for regular usage. NDPS products handling at NDPS CWH as per NDPS SOP - monitoring receipt /issue transactions with proper documents, NDPS category wise Stock maintenance in Bin Card, Register & excel sheet properly, monthly/ quarterly/ annual Return filing correctly in time, Destruction of NDPS drug products as per NDPS SOP. Regulatory compliance under PESO License for Solvents handling – stock management within limit, License renewal. Attending Regulatory Officials visits & taking appropriate action in co-ordination with Site responsible person, updating to HOD / Site Head. Monitoring & controlling Medicinal Product Stores Activities Ensure implementation of related SOPs & compliance SOP Compliance - LMS / PMS /EDMS/TRACKWISE Systems Review receipt of RLD/Test Samples, issuance, dispatch to CROs, Destruction, cleaning records. Review change control, discrepancy note, deviation through Trackwise system. Review training for adequacy & compliance in dept. thr. LMS. Ensure to get self inspection audit complete smoothly, review observations & provide response. Act as System Owner and ensure laboratory computerized systems are validated for its intended use through its lifecycle. Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle. Facilitate the user acceptant testing for laboratory computerized systems during validation. Review and approve Validation and life cycle documentations of computerized systems as per quality procedures. Provide support /response to internal/ external audit observations for laboratory computerized systems and ensure its compliance. Ensure resolution of identified risks related to computerized systems in a timely manner. Support the assessment and remediation of identified activities as part of various Corporate initiatives. Ensure GxP computerized systems are compliant to 21 CFR part 11 and EU Annex 11 readiness and adequate security and controls are available to ensure data security. Apply Now » Apply Now Start applying with LinkedIn Please wait...

Trending Job Description This role is responsible for ensuring compliance with regulatory and Pharmacopoeial standards through compendia assessments, Quality Management System (QMS) oversight, and documentation preparation. It involves collaboration with global sites, vendors, and internal teams to develop quality agreements and provide support during audits and inspections. Responsibilities also include managing SOPs, monitoring QMS events, and preparing essential quality documentation and reports. Responsibilities Conduct compendia assessments for all materials used on-site to identify gaps against current Pharmacopoeial requirements and implement risk mitigation measures to ensure compliance. Develop and implement a Standard Operating Procedure (SOP) to ensure process control and long-term sustainability of compendia assessments. Collaborate with global sites to gather and analyze data on resource requirements needed for ongoing support of compendia activities. Prepare and review Annual Stability Summary Reports in compliance with regulatory and quality requirements. Develop and establish Quality Agreements with all relevant vendors and customers, ensuring alignment with regulatory and quality requirements. Track and follow up on pending TrackWise CRFs and CAPAs. Perform effectiveness checks for closed CAPAs and CRFs. Generate and maintain statistics on quality documents (e.g., deviation closures, CRFs, RAs, CAPAs). Monitor and track SOP periodic reviews across sites. Support SOP updates, including formatting checks and revision history verification. Facilitate the creation and routing of CRFs for SOP revisions. Prepare and review OOS, OOT, and lab incident investigations; initiate change controls as needed. Review planned and unplanned deviations for accuracy, completeness, and cGMP/data integrity compliance. Collaborate with site teams to resolve gaps identified during QMS event review and documentation. Engage with customers and site teams to ensure timely closure of critical QMS events. Route documents through the ENSUR application or other platforms across Piramal plants. Participate in customer audits and regulatory inspections, supporting site teams as needed. Lead or contribute to additional assignments as directed by the Head of Department (HOD). Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8769 Posting Date 06/25/2025, 10:09 AM Apply Before 07/31/2025, 10:09 AM Degree Level Bachelor's Degree Job Schedule Full time Locations Project : Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction,, Mumbai, Maharashtra, 400070, IN

Role : CMO Corporate Quality Grade : Manager Job Summary: To ensure that SUN Pharma Quality and Compliance Standards, and applicable global regulatory authorities’ requirements are met and that all SUN affiliates, CMO, Suppliers and SUN sites / Operational Units to achieve, maintain and improve the adequate level of compliance, through “Quality Oversight” and “Independent auditing and Follow-up”. Essential Job Functions: Participate in the initial evaluation of Contract Manufacturing Organizations (CMOs). Oversee and approve Quality Management System (QMS) elements reported by CMOs, including change control, deviations, incidents, Out of Specification (OOS)/Out of Trend (OOT) results, and complaint investigations. Review and approve master documents from CMOs, such as Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), specifications, validation protocols, and stability protocols. Provide support during regulatory audits at CMO sites related to SUN Pharma product approvals. Engage in critical investigations at CMO sites, including OOS results, deviations, and complaints. Review and maintain quality agreements with CMOs to ensure compliance and quality standards. Initiate QMS documents in the Trackwise system, inform the respective CMO, and track to ensure closure of initiated QMS elements. Monitor and oversee activities carried out at CMO sites to ensure compliance with SUN Pharma standards. Review executed documents from CMOs related to SUN Product to ensure accuracy and compliance. Perform batch release of SUN products manufactured at CMO sites, ensuring they meet quality standards. Make appropriate transition related to batch releases in SAP system. Coordination with the Sun Pharma warehouse for market releases of batches, including investigating temperature excursion reports during finished product transport and addressing physical damages reported by the warehouse in finished product consignments. Conduct regular visits to CMO sites, prepare detailed visit reports, and follow up on any issues identified. Review and approval of printed packaging artwork. Review and approval of formulation orders and packaging orders, followed by master recipe approval. Involvement as quality oversight during product transfer activities. Support for the project management team during the execution of exhibit/scale-up batches at the CMO site. Preparation and review of the approved vendor list for materials supplied to the CMO site by Sun Pharma. Involvement in management notifications, batch failure investigations, and recall management. Support during annual submissions to the Sun Pharma regulatory department. Involvement in the preparation of annual schedules, annual product reviews, and quality agreements. To conduct thorough GMP Audit at Vendors (manufacturers), Raw Materials, Excipients, and Packaging Materials to SUN Pharma to ensure that they always deliver high quality and standard products and remain compliant with GMP requirements. To co-ordinate with Vendor for desired documents for pre-audit preparation, logistics, resource, so as to execute successful audit as per schedule. To outline and circulate audit agenda prior to audit. The Audit Agenda shall be prepared based on reason behind conducting GMP audit, e.g. Qualification, Surveillance or For-Cause Audit. To execute on-site audit through facility visit and review of quality management systems established in various functions such as Material Management, Production & Packing, Facility & Equipment, Quality Systems and Quality Control Laboratory, including microbiology lab, as applicable. To makes sure that, SUN Manufacturing Sites, Contract Manufacturing Organisations, and Affiliate Companies are prepared for Regulatory Agency Inspections e.g. through "Mock" inspections, audits and supports activities whenever required. To ensure during audit that, non-compliances to the requirements stated in various guidelines have been identified. To communicate the outcome of CMO Audit, based on the risk associated with the patient, regulatory compliance and business risk, to facilitate making decision of Vendor Approval / Dis-approval. To prepare Planner, Schedule, Audit Report, including non-compliances and review compliance reports thereof to close the audit. This includes performing routine follow up of performed audits to ensure timely compliance and closure of the audit. To review & approved the audit report, closure, as applicable. To maintain evidences and documents related to audit. To prepare Monthly report and to highlight the key area of concerns. To participate in the trainings to update on current / upcoming regulations. To follow the Corporate Quality Policies/ Global Quality Standards (GQS) and applicable Regulatory Guidelines. Participate and execute the project work as allotted by reporting authority. To perform the risk assessment. Basic Qualification: B. Pharmacy & M. Pharmacy Experience : 12 to 15 Yrs ( Work Experience of CMO and US market required Sterile Background)