Get alerts for new jobs matching your selected skills, preferred locations, and experience range. Manage Job Alerts
7.0 - 10.0 years
6 - 9 Lacs
vadodara
Work from Office
To ensure the GMP and GLP compliances. To participate in OOS, OOT, Deviation and complaint investigation, root cause analysis and to review investigation report. To carry out closure activities. To compile data provided by manufacturing, warehouse, QC for preparation of complaint investigation report. To prepare and review trends of OOS, OOT, Deviation, complaints, customer audit/inspection. To initiate change controls pertaining to QA and to review change controls of other departments w.r.t impacted activities. To review change control trend. To compile data for and prepare, review risk assessment reports w.r.t. Deviation, OOS, OOT, Nitrosamine impurities, elemental impurities, etc. To approve SOP preparation request, print request, training tasks, document publish request of all departments in Caliber Software. To review SOPs of all departments in Caliber software. To approve specification, STP and TDS preparation request, training tasks, document publish request of all QC department in Caliber Software. To assist conduction of customer audits and regulatory inspections. To verify the audit/inspection preparedness. To compile data and prepare the customer audit/ regulatory inspection compliance report. To convey the audit observation and activities planned for compliance along with TCD to respective departments. To perform internal audits of departments as per schedule. To compile data and prepare QRM report, presentation. To prepare minutes of meeting of QRM and convey the action plan with all departments. To prepare LOA and LOC as per requirement of customer and to assist in market response and queries. To evaluate change controls w.r.t regulatory impact. To compile data for DMF preparation of US, EP and ROW grade. To review protocols and reports of process validation, cleaning validation, general study, etc. To review vendor questionnaires.
Posted 1 day ago
15.0 - 17.0 years
20 - 35 Lacs
hyderabad
Work from Office
Role & responsibilities Suggested position: Sr Manager / Manager Education: Post Graduation (Life sciences preferred) Total Exp: 15-17 Years (Biopharma is preferred) Others: Ready to support in different shifts Responsibilities: Mainly responsible to review of Harvest, Drug Substance and Drug Product analytical (Biosimilars) raw data and analytical trends Conduct Gemba walkthroughs in QC department and to ensure quality compliance. Involve in investigations (Deviations, OOS, OOT, Lab incidents) to ensure QMS compliance for QC sections Audit trails and conduct routine monitoring in QC to check effectiveness of the system implemented. Responsible for preparation and review of documents SOPs, Protocols, Reports, Trends, APQR, Annual trends etc Track Reference standards related studies and review of related documentation timely
Posted 1 day ago
2.0 - 5.0 years
3 - 4 Lacs
hyderabad
Work from Office
Review of all quality systems i.e Change controls, Deviations, Market complaints, OOT, OOS, CAPA etc., To monitor Batch manufacturing at CMOs and review and compliance of the documents as per the requirements. To conduct/participate internal quality audits & regulatory / customer audits. Communications with External Vendors/customers for relevant information/documents Co-ordination with cross-functional teams for meeting schedule timelines for commercial and development activities. Review of development and commercial batch documents
Posted 1 day ago
6.0 - 10.0 years
5 - 8 Lacs
bavla, ahmedabad
Work from Office
Job Title: Sr. Executive Location: Bavla - Plant Department: QA Reporting To: Head of QA Employment Type: Full-Time Key Responsibilities: Prepare and review Cleaning Validation Protocols and Reports , including product matrix and MACO (Maximum Allowable Carry Over) calculations. Develop and execute protocols and reports for Clean Equipment Hold Time and Dirty Equipment Hold Time . Prepare, review, and finalize Process Validation Protocols and summary reports, utilizing analytical results and batch documentation data. Prepare and review Product Hold Time Protocols and Reports to ensure product quality throughout storage. Conduct thorough review of manufacturing documentation, including Master Formula Records (MFR), Manufacturing Process Records (MPR), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR) . Review and analyze the Annual Product Quality Review (APQR) to assess product performance and compliance. Prepare and review Standard Operating Procedures (SOPs) to ensure alignment with regulatory guidelines and internal standards. Review Stability Study Protocols and Reports to support product shelf-life determination. Oversee the preparation, review, and execution of Qualification and Validation activities for equipment, systems, and processes. Review and monitor the Training Plan to ensure effective implementation and documentation of employee training. Review and maintain Document Control Procedures to uphold quality and compliance standards. Maintain confidentiality of financial data and ensure accuracy and integrity in reporting.
Posted 3 days ago
15.0 - 19.0 years
0 Lacs
ahmedabad, gujarat
On-site
Role Overview: As a Manager in the Quality Assurance department at ZLL-SEZ Oncology Injectable (Alidac), your role will be critical in handling in-process Quality Assurance functions. You will ensure that defined and approved IPQA checks are followed and documented during Dispensing, Manufacturing, filling, capping, and Packing stages. Your responsibilities will include ensuring compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing. Additionally, you will review Smoke study protocol, report, and Video recording, and participate in regulatory audits. Key Responsibilities: - Handle in-process Quality Assurance functions by ensuring compliance with defined IPQA checks during various stages of manufacturing - Ensure compliance with Current Good Manufacturing Practices and sterility assurance activities in aseptic product manufacturing - Review Smoke study protocol, report, and Video recording, and authorize final document approval in the absence of Head Quality Assurance - Participate in regulatory audits and ensure compliance - Review and approve Process validation, cleaning validation, aseptic process simulation protocol, reports, change control, deviation, incident reports, OOS, OOT, non-conformance, and CAPA in consultation with Head Quality Assurance Qualifications Required: - M. Pharm/B. Pharm qualification - 15 to 17 years of experience in the pharmaceutical industry - 03 years of experience at Zydus - Knowledge and experience in an injectable plant Please email your CV to isha.naik@zyduslife.com for consideration.,
Posted 4 days ago
3.0 - 8.0 years
4 - 8 Lacs
hyderabad
Work from Office
Walk-In Drive for Development Quality Assurance - Formulation Department @ MSN R&D Center Pashamylaram on 20.09.2025 (Saturday ) Roles & Responsibilities 1. Issuing of Batch Manufacturing Records, Analytical Raw datas and maintaining the respective log books. 2. Issuing of registers and formats for all departments and maintaining of records for issuance and reconciliation. 3. Issuance approval, Issuance and Retrieval of the documents in eDMS. 4. Receiving, Issuing and reviewing the bio batches related executed Batch Manufacturing Records, Analytical raw datas and archiving. 5. Responsible for review of product development documents and analytical documents related to technology transfer. 6. Preparation and review of departmental SOPs 7. Reviewing of Equipment qualification protocols and Reports. 8. Review of supplier qualification documents. 9. Review of calibration documents 10. Receiving and reviewing of executed raw datas & ATRs and archiving for bio batches. 11. Reviewing of analytical method validation protocols & reports. 12. Maintenance, Retrieval and Archiving of all GMP related documents and records. 13. Preparation & review of department Schedules 14. Responsible for document distribution to the user departments. 15. Responsible for Document control activities. 16. Responsible for preparation, review and submitting License Applications. 17. Handling of Change controls (Permanent and Temporary), OOS and Incidents. 18. Responsible for approval of documents in absence of Head FDQA. 19. Responsible for performing job assigned by Head FDQA or his authorized designee. Note : Formulation R&D, API R&D Candidates also eligible for this positions Position : Executive / Senior Executive Qualification : M.Sc, M Pharma / B Pharma Only. Work Location : MSN R&D Center, Pashamylaram. Department : Development Quality Assurance - Formulation Department. Experience : 2 to 8 Years Date of Interview : 20.09.2025 (Saturday ) Interview Time : 9.00 AM to 3.00 PM Venue Details : MSN Laboratories Pvt Ltd. MSN R&D center, Pashamylaram , Isnapur, Patancheru, Sangareddy - 040-30438786
Posted 4 days ago
2.0 - 4.0 years
3 - 7 Lacs
rangpo, india
Work from Office
Division Department Sub Department 1 Job Purpose Execute the production operations in line with safety and GMP requirements to meet the manufacturing targets in shift. Key Accountabilities (1/6) Operate the equipment efficiently without error and deviation as per SOP to meet shift targets Perform unit operations as per SOP and unit processes as per batch manufacturing record Optimize the utilization of available resources for achieving production in shift Maintain equipment, facility and block premises as per SOP for audit readiness Key Accountabilities (2/6) Provide suggestions for optimization of processes to manufacture quality product Identify the deficiency in area and errors in documents and rectify them as per requirement Propose and implement new idea to enhance production, optimise the use of consumable goods and maximum utilization of resources Key Accountabilities (3/6) Execute and update online documentation to meet cGMP requirements Maintain online documentation and timely entries in BMR and supporting documents Check documentation before submission to ensure data integrity Key Accountabilities (4/6) Deliver training to workmen and adhere cGMP and safety guidelines in production process to ensure smooth operations Conduct training related to cGMP, equipment operation, safety and housekeeping for workmen Optimize the use of resources in housekeeping Ensure good housekeeping and sanitisation as per the guidelines Ensure usage and maintenance of PPEs by workmen during shifts Report any near-miss to officer in-charge in time Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Meeting shift targets due to unavailability of adequate resources. Overcome by efficient work load distribution and resource optimisation Meeting production targets due to lapses in knowledge transfer between shifts. Overcome by bridging gaps between inter-shift communication Key Interactions (1/2) Engineering & Utility for system and equipment related queries (Daily) Safety for safety rounds and PPE (Weekly) Formulation Technical Support for troubleshooting in products (Case Basis) Formulation Tech Transfer for support in new products (Project Basis) Key Interactions (2/2) Equipment manufacturer for troubleshooting in machine (Case Basis) Dimensions (1/2) Number of dosage forms : 2 Number of tech transfer supported per month : 2 Number of batches executed per month : 35-40 Achieve internal OTIF more than 90% Meet percentage utilisation of plant as per the plan 0% errors in documentation Zero reportable accidents / incidences during manufacturing Achieve 0% failures / deviations target 100% compliance to SOP Dimensions (2/2) Key Decisions (1/2) Scheduling house-keeping activities Key Decisions (2/2) Equipment Selection to Section Head Modification in plant and equipment to Production Officer Education Qualification Diploma in Pharmacy / Mechanical Relevant Work Experience 0-2 years of experience in a manufacturing organisation preferably in pharmaceutical industry
Posted 4 days ago
1.0 - 3.0 years
5 - 10 Lacs
hyderabad
Work from Office
Job Summary Roles & Responsibilities Review and approval of all analytical test data of Quality control. Review and usage decision of analytical reports in LIMS, Empower and SAP. Electronic signatures level-2 for chromatography data station (CDS) and standalone instruments. Review the Analytical test report in LIMS. Review the reported results against specification and trends. Review the method validation and method transfer documents. Review the instrument calibrations and working standard qualification records. Handling the Incidents/ Deviations, Out of Trends, Out of Specification including investigations, Corrective and Preventive actions follow up and closure. Monitoring of analytical activities in Quality control laboratory. Verification of Specifications/standard test Procedures/Worksheets/Analytical Reports before Approval. Verification and review of the audit trails for Standalone, Empower and LIMS. Ensure cGMP / cGLP compliance. To follow Safety, Health and Environmental procedures and practices. Review and approval of excel sheet validations. Review results acceptance for API and Excipients and Packing material. Review of compiled of Stability Data and its verification/ Exhibit batch sampling protocols. Handling of Robotic Process Automation of Chromatography Data review (RPACD) To carry any other activities assigned by upward reporting staff. Qualification Educational qualification: A Bachelor’s/Master's degree in Pharmacy, Chemistry, Chemical Engineering, or a related field Minimum work experience : 3 to 7 years of experience in QC or AQA department is mandatory. Additional Information About the Department Global Manufacturing Organisation (GMO) At Dr. Reddy's Laboratories, we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence, we are a leading force in the pharmaceutical industry. We operate 19 state-of-the-art manufacturing plants across Hyderabad, Vizag, Baddi, Mexico, Shreveport, and Mirfield, comprising 8 OSD facilities, 3 Injectables facilities, and 8 API facilities. Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1,150+ drug master files across key therapy areas such as Oncology, Cardio-vascular, Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally, Hyderabad, as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive, meeting business imperatives, and meeting our ambitious ESG goals. Building such ‘factories of the future’ is integral to innovation and to build healthcare of the future. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/
Posted 5 days ago
3.0 - 7.0 years
3 - 8 Lacs
ahmedabad
Work from Office
Summary Job Functions: Responsible for document review (Ex. Master MPCR/BPCR, QMS documents, SOP, Protocols & Reports) related to BBM, MSAT & R&D. Responsible for IPQA activities and Shop Floor Compliance in BBM Facility. Responsible for transactions required in software related to GMP activities Key Responsibilities: - Responsible for In-Process Quality Assurance activities (e.g. Area clearance, Issuance of MCB/ WCB/ EPCB Vial/ CI/ DS for batch processing, Verification of process steps as applicable and review of various processing parameters and its associated documentation related to BBM facility. - Review of new & revised documents and related transactions in respective software. (SOP, EBMR, BPCR, MPCR, TTD, PTN, Protocol, Report and QMS documents of BBM, MSAT and R&D). - Review of Change Controls, CAPA, Deviations, OOT, OOS and related transactions in respective software. - Preparation and Review of APQR related to CI and DS. - Responsible for Handling and review/assessment of FMS Alarm, Equipment Breakdown, SAP Incident and ERN (Error Ratification Notification) Handling. - Responsible for approval of material request from various user departments related to BBM facility. Responsible for approval/authorization of user access request related to BBM facility. - Review of Electronic record and Audit trail related to equipment/systems of BBM Facility. - Responsible for verification of BOM in SAP. Responsible for doing transactions related to BPCR review and Interim batch release in SAP. Responsible for QMS notification creation in respective software. - Responsible for EBMR/ E-Logbook Data creation, modification In SAP. Responsible for linking BOM with the effective MPCR in case of EBMR in SAP. - Monitoring and participation in Process Validation/Cleaning Validation activities of BBM. Review and compilation of Process Validation/Cleaning Validation documentation. - Participation in internal/external audits. - Preparation and review of the documents related to the quality assurance - Responsible for providing required document support to RA, R&D and DQA. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site.
Posted 5 days ago
4.0 - 8.0 years
4 - 8 Lacs
nalagarh
Work from Office
Greetings From Immacule Lifesciences Pvt Ltd! We are looking for an Injectable Production QMS experienced professionals. Position : Executive / Sr. Executive Department : Production QMS Qualification : B. Pharma / M. Pharma Experience : 4 - 9 Years Key Skills : Prepare and maintain QMS documents Manage Change Control, Deviations, and CAPA with timely closure and effectiveness check. Coordinate with QA, Engineering, QC and other departments, etc.. To Apply: Email ID : Eswar.reddy@immacule.in Mobile : 9490101534
Posted 6 days ago
4.0 - 8.0 years
6 - 8 Lacs
kheda
Work from Office
QMS Documentation: Handling change control, deviation, CAPA (Corrective & Preventive Actions), complaints, OOS (Out of Specification), OOT (Out of Trend), etc. Audits & Compliance: Risk Assessment: Product Quality Review (PQR)
Posted 6 days ago
3.0 - 7.0 years
0 Lacs
indore, madhya pradesh
On-site
Dear Candidate, THINQ Pharma is currently seeking a QA-QC professional for the Pitampur location. As a QA-QC specialist, you will be responsible for reviewing and controlling all Quality Management System (QMS) related documents such as change control, deviations, out of specification cases, Corrective and Preventive Actions (CAPA), and incidents. Additionally, you will review master Batch Manufacturing Records (BMR) and Batch Packing Records (BPR), Standard Operating Procedures (SOP), and specifications. Your role will also involve participating in internal audits, coordinating for compliance and closure, conducting root cause and risk assessments, and reviewing and maintaining various executed documents including BMR, BPR, cleaning documents, logbooks, formats, and analytical data. In this position, you will be responsible for the issuance and retrieval of all types of formats, logbooks, and other documents, as well as the effective control and distribution of SOPs, specifications, Standard Testing Procedures (STP), BMR, BPR, and other master documents. You will also be involved in the preparation and review of Annual Product Quality Review (APQR), revision of Finished Goods labels and related activities, and ensuring document and data control within the organization. THINQ Pharma offers a flat organizational structure with an open-door policy, providing new employees with great exposure and performance-related rewards. The company is currently in an expansion phase, with plans to increase the number of stores and explore new business avenues, offering challenging opportunities for growth within the organization. The salary structure will be discussed during the personal interview round, based on your fitment for the role and as per industry standards, with a competitive compensation package assured. The interview for this position will be conducted by the HR Manager, and functionally you will report to the specified authority. With over 100 employees working at THINQ Pharma, you will be part of a dynamic team that supports and nurtures talents in an open culture. If you are interested in this full-time QA-QC position, please review the job description and company details provided and revert with your updated CV at the earliest. Thank you for considering a career opportunity with THINQ Pharma. Thanks & Regards, Naina 8319348037 Benefits: - Health insurance - Provident Fund,
Posted 1 week ago
3.0 - 7.0 years
0 - 0 Lacs
nagpur
Work from Office
Job Description 1. Preparation and review of operational packing materials list, Packaging materials specifications, Packaging materials specifications base documents, BOM, BPR (PAS X and SAP), In House Labels for Exhibit Batches, Pack Split Up and Pallet Matrix. 2. To provided technical support to Production, QA, QC and RA. 3. Review of Artwork, Shade cards and print proof etc. Initiate Change controls, Deviation and CAPA and close all action item of change control, CAPA and deviation within time frame preparation of investigation report of deviation. Coordinate with R&D and QA for Primary Packaging Materials Specifications, Primary Pack Specification and Standard Test Procedures. 4. Preparation and Review of SOP’s, Protocols and Reports. Supervise compliance to all cGMP or any other regulatory requirements, including EH&S requirements. Execute and supervise all tasks and activities as per applicable SOP’s. Work Experience 2-4 years Education Graduation in Pharmacy Diploma in Packaging Technology Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence
Posted 1 week ago
1.0 - 3.0 years
3 - 4 Lacs
mumbai suburban
Work from Office
-Check documents like packing sheets, Temp Records, Logger readings -Exp with CAPA documentation -Monitor & maintain the temperature systems -Provide training & prepare training records -Branch visit & perform self inspection activity for branches Required Candidate profile -Male/Female willing to travel -Exp in food/pharma industry preferred -Exp in CAPA documentation is a MUST -Excellent verbal and written communication skills Perks and benefits PF, ESI, Mediclaim, Bonus, PL
Posted 1 week ago
1.0 - 5.0 years
3 - 4 Lacs
pune
Work from Office
Job Description Join Lupin Limited's dynamic Quality division as an Officer within our Validation department based in Pithampur. In this pivotal role, you will take charge of the cleaning validation activities for our API and Formulation facilities. Your responsibilities will encompass comprehensive management and execution of validation protocols supporting our commitment to the highest quality manufacturing standards. Your core duties will include ensuring rigorous residue cleaning validation processes to maintain contamination-free production environments. You will manage and evaluate nitrosamine and genotoxic cleaning validation activities, essential to safeguarding product safety and regulatory compliance. In addition, you will perform risk priority number (RPN) calculations to identify and mitigate potential risks effectively. Campaign studies including CEHT/DEHT will fall within your scope, enabling process optimization and validation integrity. The role extends to qualification activities for facilities, equipment, utilities, and HVAC systems, ensuring all operate at validated standards aligned with industry and regulatory requirements. As the Officer, you will prepare and review validation-related documentation with precision, supporting audit readiness and continuous improvement initiatives. Your efforts will directly contribute to Lupin's mission of delivering safe, efficacious pharmaceutical products to global markets. We seek an individual with a keen eye for detail, exceptional organizational skills, and the ability to collaborate cross-functionally. Your proactive approach to validation and quality processes will drive success and uphold our high standards. At Lupin Limited, you will be part of a culture that values innovation, strategic thinking, and continuous development. Join us to advance your career in a challenging and rewarding environment where your expertise makes a meaningful difference. Work Experience Applicants should have between 2 to 5 years of relevant experience in pharmaceutical cleaning validation or quality assurance sectors. Experience in executing and managing cleaning validation protocols, facility and equipment qualification, as well as working knowledge of regulatory requirements related to pharmaceutical manufacturing, will be highly valued. Education Graduation in Pharmacy Competencies Strategic Agility Innovation & Creativity Customer Centricity Developing Talent Result Orientation Process Excellence Collaboration Stakeholder Management
Posted 1 week ago
7.0 - 11.0 years
0 Lacs
ahmedabad, gujarat
On-site
As a member of our team at Meteoric Biopharmaceuticals, your role will involve various responsibilities related to Human Resources. You will be responsible for Talent Acquisition and Management, ensuring we have the right individuals on board to drive our organization forward. Additionally, you will oversee Onboarding and Offboarding processes, ensuring a smooth transition for new hires and departing employees. Employee Relations and Engagement will be a key focus of your role, as you work to foster a positive and inclusive work environment. Performance Management will also fall under your purview, as you support employees in reaching their full potential through feedback and development opportunities. Training and Development programs will be designed and implemented by you to enhance the skills and knowledge of our workforce. You will also be involved in developing Compensation and Benefits strategies to attract and retain top talent. Ensuring HR Policies are in compliance with regulations and effectively communicated to all employees will be crucial. You will also be responsible for HR Analytics and Reporting to provide data-driven insights to support decision-making. Change Management and Organizational Effectiveness will be areas where you will play a key role, driving initiatives to adapt to the evolving needs of the organization. Stakeholder Management and Leadership will be essential as you collaborate with various teams and guide HR functions. Furthermore, you will conduct HR SOP training for new joiners and refreshment training for all employees to ensure adherence to standards. Documentation in alignment with Quality Management System standards will also be part of your responsibilities, including GDP, CAPA, Change Management, Risk Assessment, Deviation, and maintaining Training Records. If you are a proactive and detail-oriented HR professional with a passion for driving organizational success through effective people management, we encourage you to apply for this role and be a part of our dynamic team at Meteoric Biopharmaceuticals.,
Posted 1 week ago
8.0 - 12.0 years
11 - 19 Lacs
bengaluru
Work from Office
Manage day-to-day quality operations and documentation reviews related to contract/loan-license manufacturing of soft gel capsules. Review and ensure timely closure of: Deviations and Investigations Change Controls CAPAs Coordinate the review of Batch Documentation, Certificates of Analysis (CoAs), and related product quality documentation. Facilitate communication and resolution of quality matters between: Manufacturing sites (CDMO/LL partners) Internal departments (Supply Chain, QC, RA) External customers (on quality queries/documentation) Support management of product-specific documentation such as: Specifications and Test Methods Master Manufacturing Records (MMRs) Packaging components and artworks Track progress of quality actions and drive adherence to quality KPIs and timelines. Assist in supplier qualification processes, including documentation collation and audit support. Prepare for and support internal/external audits and regulatory inspections. Train junior quality staff and foster a culture of compliance and continuous improvement.
Posted 1 week ago
10.0 - 17.0 years
9 - 15 Lacs
chennai
Work from Office
QA Manager OSD/Liquid formulation background.Must have experience in BMR, batch release,validations,qualifications,SOPs,GMP,audits,QMS(Deviation,OOS, OOT, CAPA), tech transfer. Analytical exposure is an added advantage Resume to hrd@stedmanpharma.com
Posted 1 week ago
2.0 - 6.0 years
12 - 17 Lacs
pune
Work from Office
Overview The Enterprise Operations and Quality team oversees the data, services, and applications within the Climate and Sustainability Engineering and MSCI's Data Technology verticals. Our primary responsibility is to manage and support end-to-end Quality Engineering by creating tools and tests that ensure continuous quality assessment of applications, services, and generated data. MSCI is renowned for its high-quality data, which is crucial for critical investment decisions, and our role is vital to this mission. Responsibilities Develop and implement engineering solutions to address complex data validation challenges. Develop code in Python and/or Java to maintain high-quality data integrity. Design and implement automation frameworks (distinct from traditional Selenium-based programs) to test data dimensions across complex environments, with the capability to handle big data. Qualifications Hands on experience of day to day development of data critical applications 8+ years of experience in quality engineering. Proficiency in coding with Python and Java. This is a technical role, not a managerial position. What we offer you Transparent compensation schemes and comprehensive employee benefits, tailored to your location, ensuring your financial security, health, and overall wellbeing. Flexible working arrangements, advanced technology, and collaborative workspaces. A culture of high performance and innovation where we experiment with new ideas and take responsibility for achieving results. A global network of talented colleagues, who inspire, support, and share their expertise to innovate and deliver for our clients. Global Orientation program to kickstart your journey, followed by access to our Learning@MSCI platform, LinkedIn Learning Pro and tailored learning opportunities for ongoing skills development. Multi-directional career paths that offer professional growth and development through new challenges, internal mobility and expanded roles. We actively nurture an environment that builds a sense of inclusion belonging and connection, including eight Employee Resource Groups. All Abilities, Asian Support Network, Black Leadership Network, Climate Action Network, Hola! MSCI, Pride & Allies, Women in Tech, and Women’s Leadership Forum. At MSCI we are passionate about what we do, and we are inspired by our purpose – to power better investment decisions. You’ll be part of an industry-leading network of creative, curious, and entrepreneurial pioneers. This is a space where you can challenge yourself, set new standards and perform beyond expectations for yourself, our clients, and our industry. MSCI is a leading provider of critical decision support tools and services for the global investment community. With over 50 years of expertise in research, data, and technology, we power better investment decisions by enabling clients to understand and analyze key drivers of risk and return and confidently build more effective portfolios. We create industry-leading research-enhanced solutions that clients use to gain insight into and improve transparency across the investment process. MSCI Inc. is an equal opportunity employer. It is the policy of the firm to ensure equal employment opportunity without discrimination or harassment on the basis of race, color, religion, creed, age, sex, gender, gender identity, sexual orientation, national origin, citizenship, disability, marital and civil partnership/union status, pregnancy (including unlawful discrimination on the basis of a legally protected parental leave), veteran status, or any other characteristic protected by law. MSCI is also committed to working with and providing reasonable accommodations to individuals with disabilities. If you are an individual with a disability and would like to request a reasonable accommodation for any part of the application process, please email Disability.Assistance@msci.com and indicate the specifics of the assistance needed. Please note, this e-mail is intended only for individuals who are requesting a reasonable workplace accommodation; it is not intended for other inquiries. To all recruitment agencies MSCI does not accept unsolicited CVs/Resumes. Please do not forward CVs/Resumes to any MSCI employee, location, or website. MSCI is not responsible for any fees related to unsolicited CVs/Resumes. Note on recruitment scams We are aware of recruitment scams where fraudsters impersonating MSCI personnel may try and elicit personal information from job seekers. Read our full note on careers.msci.com
Posted 1 week ago
2.0 - 5.0 years
3 - 6 Lacs
jammu
Work from Office
Job Description Department: Production Designation: Jr. Officer - Production (E0) Working Section: Granulation / Compression / Coating Comply with all cGMP, GxP and any other applicable regulatory requirement, including EH&S requirements. Complete training on relevant SOPs and develop an understanding of the activities to be conducted prior to undertaking any task. Conduct all tasks/activities as per the applicable SOPs. Report any difficulty or deviation in following the procedure/instruction to immediate supervisor/managers. Report any quality concern or suggestion for improvement to supervisors/ managers. Manufacturing / processing of batches of assigned products under supervision as per instructions given in the BMR. Handling and movement of raw material, bulk, semi-finished and finished goods. Operation, washing and cleaning of equipment’s and accessories used in related production activities as per respective SOP. Up-keeping area and machines as per GMP requirements. To Support Quality Management Systems and to report any discrepancy, abnormity, non-conformance or any incidence observed to the Department Head and QA Head. Receipt of RM and PM from Warehouse and ensuring overall cleanliness of areas. Doing operations as per the SOPs and BMR with online recording in respective documents as applicable. To ensure self-hygiene before entering in the production area and follow all the other rules & regulation set by HR department. Performing in-process checks as per respective BMR and recording of results of in respective documents as applicable. To fulfil the training need as per current needs with respect to cGMP, Job, safety, health & Hygiene by attending the training programmes. Cost effectiveness in production operation by controlling overtime, revenue expenses and achieving standard yield. Critically monitoring of the environmental conditions with a view to meet the standards mentioned in BMR and SOP. Ensure calibration and preventive maintenance of manufacturing equipment and instruments as per approved schedule and the results of same meeting the standards. To perform line clearance activity during batch to batch and product to product change over and ensure the compliance as per SOP. Issuance, retrieval and destruction of dies and punches, product dedicated bags and sieves, silicon sleeves, pipes, hose pipes and screens. To ensure the audit compliance. Trouble-shooting: To attend the problems of machine and process as and when necessary. Any other assignment allocated by production Head. To attend required cGMP/ On Job /Functional training activities as per planner. Work Experience Minimum 3 years, maximum 5 years Education Diploma Vocational Competencies Customer Centricity Developing Talent Collaboration Strategic Agility Process Excellence Stakeholder Management Innovation & Creativity Result Orientation
Posted 1 week ago
2.0 - 5.0 years
3 - 5 Lacs
valsad, dadra & nagar haveli, daman & diu
Work from Office
Role & responsibilities 1. To review batch release documents for raw material/packing material /in process/intermediate /finished product/stability like test protocol / report, electronic data, chromatograms, audit trail, spectra, etc. 2. To execute audit trails and review the activity to verify the integrity of data. 3. To review electronic data back up and verification of restoration study, computer system validation, etc. 4. To review calibration/qualification/PM schedule/installation documents for instruments in Quality Control department. 5. To review analyst qualification and training related documents of quality control department. 6. To review documents related to working standard / reference standard / impurity standard / reference material / GC standard. 7. To review stability schedule and related analytical data. 8. To review holding time stability study data & related analytical data. 9. To review quality management system related activity for Quality Control (Change Control, Deviation, Quality Complaints, QRM). 10. To review investigation and ensure closure of laboratory incidents. 11. To review investigation and ensure closure of OOS/OOT/OOC in Quality Control department. 12. To review all the trends related to quality control activity 13. To review of documents related to microbiological activity like, environmental monitoring, water testing, finished product testing, validation-based testing, instrument calibration and validation activities, etc. 14. To take QC rounds and support in maintaining GLP, logbooks review, etc. 15. To review SOPs, specification and method of analysis, test reports / protocols / documents related to QC. 16. Review of analytical method transfer and analytical method validation documents.
Posted 1 week ago
3.0 - 7.0 years
0 Lacs
indore, madhya pradesh
On-site
You will be responsible for equipment validation and Quality Management System (QMS) related activities. Your main duties will include the preparation, review, execution, and compilation of validation protocols for in-house Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) of all equipment and systems used in Injectable production at the Indore site. Additionally, you will ensure that Periodic Performance Verification (PPV) is conducted and approved according to the PPV schedule. As part of your role, you will be required to manage a team and allocate tasks effectively. You will also oversee the QMS system, including handling change control, deviations, Corrective and Preventive Actions (CAPA) related to validation activities. In case of deviations and non-conformances identified on the shop floor, you will be responsible for conducting investigations and implementing corrective actions and CAPA within the specified timeline. Your commitment to Diversity, Equity, and Inclusion is highly valued in this role.,
Posted 1 week ago
10.0 - 14.0 years
0 Lacs
mumbai, maharashtra, india
On-site
Job Description Business: Piramal Critical Care Department: Information Technology Location: Kurla Travel: Low Job Overview To perform and document Computer System Validation of GxP Systems as per defined processes at Central Partner Functions and across Piramal Critical Care sites. Key Stakeholders: Internal Business Site / Central Partner functions IT Team (e.g. SAP / Infra / Quality IT / Allied / SAP etc) Key Stakeholders: External IT Vendors, IT Contractors/Consultants, Piramal CSV Partner Reporting Structure Reports to: AGM IT - CSV Education Qualification & Experience Graduate in Science/Pharmacy/Engineering Post Graduation MPharm/Science/MBA (Desirable) Candidate with 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity Work experience in Pharma or IT Sector will be desirable Roles & Responsibilities Must have thorough understanding, practical approaches for Computer system validation (CSV) & Computer Software Assurance of enterprise level applications. Accountable to ensure compliance of CSV documentation during various phases (project, operational & retirement) of software lifecycle (SLC).Well aware with GAMP5, CFR Part 11/EU Annex 11 and Data integrity requirements. To create end to end CSV deliverables for IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms. To perform Root cause analysis and define CAPA based on QMS documents review. To support Quality Automations Initiatives across the Central Partner functions/PCC/PPL sites. To liaise with Site IT , Business SPOCs for CSV activities and IT Compliance initiatives. To guide and train IT & CSV teams (Central Partner Functions & Site) for CSV, and CSV Regulatory Compliance activities. To work along with Business, IT, QeC & Project Manager to ensure project timelines are met. Experience on validation of any of the enterprise level applications. e.g. Track wise, Ensur/Documentum, Paperless Validation Tools, LIMS, LMS, SAP, RIMS Applications, Artwork management Systems, Serialization, Veeva etc. Author, review and approval of SOPs, Guidelines/Policies as applicable. Competencies Good knowledge of 21 CFR Part 11 / Annexure 11 (Must) Good knowledge of CSV, CSA,GAMP 5 Guidelines (Must) Good knowledge of Data Integrity requirements for Pharma (Must) Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must) Experience of working with Global Pharma Cross functional Sites QC, QA, Manufacturing, IT, SAP etc. (Plus) Experience of validation on automation/digitization projects (Plus) Good Verbal and Written communication skills (Must) Aware of industry best practices and knowledge about Pharma 4.0 (Plus) Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Plus) Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) 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 Critical Care (PCC), under Piramal Pharma Limited (PPL), a subsidiary of Piramal Enterprises Limited, is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics. Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe, PCC is committed to enabling sustainable and profitable growth for all its stakeholders. PCC maintains a wide presence across the USA, Europe and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management. PCC has wholly-owned, state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA, UK MHRA and other regulators. Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries. PCC is focused on further expanding its global footprint through new product additions in the critical care space. Committed to corporate social responsibility alongside Piramal Group, PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need, as well as caring for the environment. Show more Show less
Posted 1 week ago
2.0 - 5.0 years
4 - 8 Lacs
navi mumbai
Work from Office
Sr. Executive- Talent Acquisition is responsible for driving the recruitment team to meet and exceed hiring targets within defined timelines while ensuring process adherence, data accuracy, and high-quality delivery. The role demands strong leadership to manage team productivity, skill development, and performance enhancement. This individual will work closely with TA vertical leads to execute strategic hiring plans, foster diversity hiring, and streamline recruitment processes for better efficiency and stakeholder experience. Key responsibilities include monitoring and reporting performance metrics (SLA, source mix, compliance, quality), promoting effective communication within the team, ensuring full adoption of ATS/HRIS tools, and overseeing training initiatives to strengthen sourcing and hiring capabilities. Roles & Responsibilities- Drive the team to achieve and exceed set hiring goals within specified timeframes. Ensure the accuracy and completeness of all data related to recruitment activities, along with timely and accurate sharing of relevant recruitment data based on organizational needs. Ensure that the TA metrics, such as SLA’s, Source Mix, diversity hiring, compliances, processes and Quality is adhered for team and themselves. Leads to ensure clear and consistent communication providing updates on targets, achievements, and challenges. Leads to collaborate with TA vertical leads to implement and execute talent acquisition strategies. Leads to source and recruit through a different sourcing channel within the SLA. Improve process to ensure the efficiency and quality of hiring as well as better experience for both hiring managers and candidates. Leads to timely review the performance & publish the reports to supervisor Ensures that the leads are responsible for arranging and taking the trainings for recruiting to enhance sourcing and hiring skills. Ensure 100% adoption of HRIS/ATS Qualifications: Master’s / bachelor’s degree in human resources or a related field. 5+ years of experience in talent acquisition, recruiting, people management, continuous improvement. Strong understanding of talent acquisition best practices. Excellent communication and interpersonal skills. Ability to manage a team independently. Strong problem-solving and analytical skills. Ability to meet deadlines and manage multiple projects simultaneously. Morningstar is an equal opportunity employer.
Posted 1 week ago
5.0 - 10.0 years
0 - 0 Lacs
dahej
Work from Office
He should know computer good computer knowledge He should know and having expertise in Good Manufacturing Practices (Developing, implementing. Required Candidate profile And maintaining quality systems and procedures ( Deviation/OOS investigation , batch card /SOP drafting ) that align with regulatory requirements.
Posted 1 week ago
Upload Resume
Drag or click to upload
Your data is secure with us, protected by advanced encryption.
Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.
We have sent an OTP to your contact. Please enter it below to verify.
Accenture
73564 Jobs | Dublin
Wipro
27625 Jobs | Bengaluru
Accenture in India
22690 Jobs | Dublin 2
EY
20638 Jobs | London
Uplers
15021 Jobs | Ahmedabad
Bajaj Finserv
14304 Jobs |
IBM
14148 Jobs | Armonk
Accenture services Pvt Ltd
13138 Jobs |
Capgemini
12942 Jobs | Paris,France
Amazon.com
12683 Jobs |