199 Trackwise Jobs - Page 7

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: Senior Executive Date: May 23, 2025 Location: Jammu - Operations Company: Sun Pharma Laboratories Ltd To ensure proper receipt of packing material & misc material after proper verification of documentation, preparation of GRN. To ensure proper verification and segregation of material before preparation of GRN. To ensure material is stored as per locator codes. To ensure proper issuance of packing material from production department. To ensure proper returns of issued packing material from production department. To ensure proper maintenance of documents and records. To prepare MDN's as per SOP as & when required. To ensure day to day records of humidity / tempreture/ performance of weighing scales is being carried out and recorded. To ensure proper handling of rejected material as per SOP. To ensure proper disposal of scrap as and when rquired. To ensure timely release of packing material for production. To generate requirement of packing material and place purchase requisition as per RFC. To follow Trackwise, EDMS for change controls and revision of SOP's as and when required. To maintain the records for calibration, validation of all the equipments installed in warehouse. To reconcile all packing materials as and when required and maintain proper locator codes. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Executive Production Packing Supervisor Date: May 24, 2025 Location: Dewas SGO - Operations Block B Company: Sun Pharmaceutical Industries Ltd Role & Responsibility: To meet the production schedule both in quality and quantity. To maintain good discipline in the Packaging area and department. To ensure the implementation of EHS practices during the work To plan the activities of the area as per daily basis schedule To plan & allocate different jobs on daily basis to workmen/ machine operators of Secondary and primary Packing area. To check and verify the transfer of Primary Packing Material from P.M. staging to process area To ensure implementation of Good Packaging Practices and SOP during work. To maintain and improve quality of the products as per standard’s. To ensure the effective control on usage of men, machine and material in the department. To participate and co-ordinate various ongoing validation activities of equipment and system. To organize and implement the on-job training activities in the department. To supervise the Primary and Secondary Packing activities To ensure training completion of all employees working in secondary and primary area activities.. To conduct investigation of OOS, monitor CAPA and handle deviations. To ensure instruction of validation protocols, change controls, deviations, SOPs and specifications relating to production and ensure their strict implementations.. To maintain department and equipment in neat and tidy condition all the time. To control the rejection during secondary and primary packaging operations. To do counseling and grievance handling of the subordinates. To review the Batch Production Records after completion of the BPR. To perform any other related work allotted by the superior as per the production requirement. To work for the control of wastages during Packaging and to achieve higher yields of product. To perform all the trackwise and SAP related work. Any other responsibility to be completed that may be assigned for time to time. To perform investigation for Market Complaint and Deviations & handling of change controls. Completion of all the record work on daily basis Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Manager - Corporate Quality Compliance (Compliants) Date: May 23, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Job Title: Manager Job Grade: M2 Function: Corporate Quality Compliance Sub-function: Complaints Manager’s Job Title: Senior Manager-1 Location: Vadodara Job Responsibilities Review of Product Quality Complaint Investigation Reports (US Market). Coordinate with other stakeholders involved in the complaint handling process. Monitor the progress of Filed Alert Reports, Recalls & Product Quality Complaint closure. Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Providing the response letter to the complainant. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints Management Travel Estimate Approximately 10% Job Requirements Educational Qualification M.Sc (Life Sciences) / B.Pharm Specific Certification Nil Skills Good Technical & Communication Skills, Investigation writing, reviewing, and editing experience, candidate should have worked in USFDA work environment. Experience 13-14 years Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Senior Manager - Corporate Quality Compliance Date: May 23, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Position: Senior Manager Sub-function: Global Actions Management Function: Corporate Quality Compliance Function Head Title: Sr. General Manager Location: Vadodara Areas of Responsibility Ensure assessment of Regulatory inspection citations identified at Sunpharma sites to derive the global action Ensure assessment of 483s, warning letter issued to other organization by USFDA to derive the global action Ensure assessment of internal learning (such as Quality alert) to derive the global action Preparation of Global action based, following are the sub-activities: v. Review of the regulatory guidance related to the topic vi. Review of existing site practices vii. Drafting of Global action recommendations viii. Preparation of reference procedures and associated formats for Global action implementation as applicable ix. Finalization of Global action recommendation post review with Global action committee and relevant stakeholders Ensure issuance and approving of Global actions in Trackwise. Coordinating with sites for the implementation of Global action recommendations Ensure review of site action closure for completeness and correctness Ensure closure of global action upon completion of all issued site action records of a global action Ensure circulation of Global action status to relevant stakeholders Ensure compliance calls being executed as per pre-defined agenda i.e. internal and external learnings being shared and explained with stakeholders. Ensure identified gaps being shared across sites and tracked for implementation Ensure maintenance of database for regulatory inspections at SUN Pharma Review of draft response of inspection observation Ensure Sun site regulatory inspection observations trend is in place for meaningful analysis All other duties as assigned by Head Corporate Quality Compliance and CQA Travel Estimate Approximate 30% Job Requirements Educational Qualification M.SC / M. Pharm Specific Certification Not specific Skills Quality Management System, Compliance, CAPA, Investigations, Audit Management, Supplier Qualification, Change Management, Manufacturing and Engineering Assurance (OSD and Sterile) Experience Minimum 15 years Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Executive Date: May 26, 2025 Location: Tandalja - R&D Company: Sun Pharmaceutical Industries Ltd Position: Executive Job Title: Executive - CQC Job Grade: G12A Function: Corporate Quality Compliance Sub-function: Product Quality Complaints Manager’s Job Title: Senior Manager-1 Skip Level Manager’s Title: Head of Global Quality Systems Complaints Function Head Title: Linda Savage Location: R & D Tandalja, Vadodara No. of Direct Reports (if any) Nil Job Summary Logging of Product Quality Complaints (PQC) in the database (TrackWise). Acknowledge the complaints to the complainants. Follow up with the complainant for complaint sample and additional information to support Product Quality investigation. Providing the response letter to the complainant. Coordinate with other stakeholders involved in the complaint handling process. Reconciliation of received market complaints. Areas of Responsibility Product Quality Complaints log in management. Travel Estimate Less than 5% Job Scope Internal Interactions (within the organization) Yes External Interactions (outside the organization) Yes Geographical Scope India Financial Accountability (cost/revenue with exclusive authority) Nil Job Requirements Educational Qualification M.Sc / B.Pharm Specific Certification Nil. Skills Hands on experience in computer handling. Good Knowledge in MS Office. Fluency in English. Experience 0 to 3 years Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s). Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

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: Manager, Microbiology Date: May 9, 2025 Location: Dadra - Quality Control Company: Sun Pharmaceutical Industries Ltd Manager, Microbiology Location: Dadra Designation: Manager 2 Education: BSc / MSc in Microbiology Experience: 10+ Years Maintain the microbiology laboratory as per regulatory requirements. Planning and coordination with cross functional team for timely release of the RM,FP, Stability samples. Handling of microbiology related OOS/OOT, Deviation, Lab event. Prepare the response and closure of audit observations. Change control management for revision of SOP’s, Validation protocol. Ensure the availability of resources of microbiology laboratory. Ensure the microbiologist certification program of all microbiologist. Implementation of new projects for cost saving, compliance enhancement , work simplification. Having technical knowledge of following major test MLT of OSD products and MLT validation. Disinfectant efficacy test ( Disinfectant Validation) Maintenance of microbial cultures Maintenance of Microbiological media, Growth promotion test. Autoclave validation LAF, Biosafety cabinet, Incubators, pass box validation. Objectionability assessment of identified inhouse isolates. ALCOA++ Good knowledge of various guidelines like ISO14644, HTM 2010, EU Annex 1, 4, WHO, USP chapter 60, 61, 62, 1115, 1116, 1072, 21 CFR regulations Part 210, 211 Environment monitoring program design, risk evaluation, Location selection, Alert and action limit establishment. Purified water system validation. Chemical and microbial analysis of water. Audit experience for FDA, MHRA. ANVISA, TGA etc. Handling of software following but not limited: SLIMS, Lonza Moda, Equisoft, Vitek 2 compact software, High air flow, ICDAS, Trackwise, EDAMS, LMS, e residue , Lab X software, TOC software Hands on experience of major instruments like: Vitek 2 system, TOC analyser, Autoclave, Conductivity meter, Air sampler, Digital Microscope, LAF, Biosafety cabinet. Apply Now » Apply Now Start applying with LinkedIn Please wait... Show more Show less

Preferred candidate profile Qualification : B Pharma/ M Pharma Experience : Min 3 years in QMS in OSD TrackWise Change control CAPA Deviation Others : Shift : General Female candidates are also eligible. Interested candidate may share resume at hr.plant@zuventus.com

Trending Job Description Provide remote analytical support to PPL sites, including review of analytical data and preparation of documents such as specifications, test methods, and protocols. Upload documents for review in ENSURE and initiate QMS elements in TrackWise/eDMS. Prepare and review stability protocols and reports, and perform stability data trending and analysis Responsibilities Review of analytical data generated in the analytical lab (QC/AS) including but not limited to Cleaning verification data, IPC, raw materials, intermediates, finished products, cleaning verification/validation, stability, and method validation data according to cGMP, GDP, in a timely manner. Review of reports for accuracy and completeness. Reports may include but not limited to: method validation reports, stability reports, lab equipment and instrumentation Calibration and Preventive Maintenance (PM) Reports, etc. Knowledge in analytical data review in Empower/Chromeleon/Open-Lab/Lab-Notebooks/LIMS/QMS module. Analytical Method Development and Documentation: Create and revise working test methods in compliance with compendia requirements and laboratory practices to support analytical testing. Change Request Forms (CRF) Management: Routinely initiate and manage Change Request Forms via the TrackWise system, including updates to product specifications and Certificates of Analysis (COA). Data Trending and Out-of-Trend (OOT) Analysis: Perform trend analysis of release testing data to identify OOT results. Develop, implement, and maintain procedures for trending and statistical data evaluation. External Data Review: Review analytical data generated by external laboratories to ensure compliance with specifications and quality standards. Share the review deficiencies with site team for further actions. Develop, revise, and review stability protocols and documentation in accordance with ICH guidelines and product-specific requirements, prepare stability summary reports with statistical analysis and trending to evaluate data and ensure regulatory compliance and data integrity. Conduct thorough Compendia reviews of USP (United States Pharmacopeia) monographs and ensure alignment with internal specifications and regulatory expectations. To participate and support site during customer audits and regulatory inspection. Lead and participate any other task assigned by HOD. Qualifications B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent Job Info Job Identification 8774 Posting Date 06/03/2025, 08:30 AM Apply Before 06/30/2025, 08:30 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 Show more Show less

Trending Job Description This role supports Quality Management System (QMS) activities including tracking and reviewing CRFs, CAPAs, deviations, and SOPs across multiple sites. Responsibilities include documentation control, data analysis, digital transition support, and coordination with site teams to ensure compliance with cGMP standards. The position also involves audit support, workflow optimization, and cross-functional collaboration to drive timely closure of quality events Responsibilities 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. Assist in the transition from physical to electronic forms (Leucine project). Support the review of manufacturing documentation (e.g., shipping/receiving logs, PM records). Collaborate on defining and improving document workflows and review processes. 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. Coordinate site review activities and ensure workflow efficiency. 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 8772 Posting Date 06/03/2025, 08:44 AM Apply Before 06/30/2025, 08:43 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 Show more Show less

Job Purpose: To ensure effective and timely management of product complaints by receiving, documenting, investigating, analyzing, and resolving product-related complaints in compliance with applicable regulatory requirements (e.g., ISO 13485, FDA 21 CFR Part 820, MDR). The role supports continuous improvement of product quality and customer satisfaction. Key Responsibilities: Receive and log product complaints from customers, sales team, or regulatory bodies in the complaint management system. Acknowledge receipt of complaints and communicate resolution timelines to complainants. Evaluate the complaint to determine if it qualifies as a reportable event per regulatory requirements. Coordinate with cross-functional teams (R&D, Quality, Manufacturing, etc.) to investigate root cause(s). Ensure timely and accurate completion of complaint investigations, CAPA initiation (if required), and closure within defined timelines. Document complaint details, investigation findings, corrective actions, and outcomes. Communicate findings and resolutions to stakeholders and customers. Generate monthly/quarterly complaint trend reports and risk assessments. Support external/internal audits and regulatory inspections by providing complaint-related documentation. Maintain compliance with company SOPs, ISO standards, and regulatory requirements. Recommend preventive actions and contribute to quality improvement initiatives. Required Qualifications and Skills: Bachelor’s degree in Pharmacy, Science, Biomedical Engineering, or equivalent field. 3+ years of experience in product complaint handling, preferably in the medical device or pharmaceutical industry. Knowledge of ISO 13485, FDA regulations, MDR, and other global regulatory requirements. Strong analytical, problem-solving, and documentation skills. Familiarity with complaint management software or QMS tools (e.g., TrackWise, MasterControl, etc.). Excellent communication skills – written and verbal. Attention to detail and a commitment to quality and compliance. Preferred Qualifications: Certification in Quality Management Systems or Regulatory Affairs. Experience in root cause analysis tools (e.g., 5 Whys, Fishbone, FMEA). Exposure to CAPA, NC, and audit handling processes. Show more Show less

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. Show more Show less

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role Veeva’s Vault Quality suite is a single authoritative source, enabling greater visibility and control. Vault Quality enables organizations to modernize quality management, assuring quality while driving compliance and operational innovation. We are looking for Consultants with Life Sciences experience and a passion for helping customers optimize their quality data and document management operations in the cloud. What You'll Do Participate in projects at life sciences companies designing and deploying Quality systems Support Functional Analysts in workshops and be part of customer discussions of the Vault Quality suite (Vault QMS, Vault QualityDocs, Vault Training) Quality/Content management solution design, prototyping, configuration, and documentation Solution and configuration of Veeva Vault Quality Suite per customer requirements, including workflows, document types, security, fields, page layouts, reports, dashboards, formatted output reports, and notifications Leveraging enablement of out-of-the-box or best practices configuration approach to solution strategy Assessing the impact of change on the current configuration and working with key stakeholders to make informed decisions in a timely manner Represent Professional Services across multiple engagements and workstreams (e.g., solution design and configuration, data migration, systems integration, etc.) Ensure customer success from the beginning to the end of the engagement life cycle Requirements 4+ years of experience implementing Document or Quality Management systems for life sciences as a consultant, business, or IT representative Bachelor's Degree in Life science, computer science, or related degree Solid analytical and great interpersonal skills Excellent communication skills (written and verbal) Strong attention to detail Highly organized Ability to act with speed to understand business requirements and willingness to "roll up your sleeves" to design and implement a solution Exposure to life sciences compliance and computer systems validation requirements Nice to Have Understanding of global quality requirements, compliance considerations, and processes for Quality process and content management, life sciences compliance, and/or computer systems validation Proven track record leading high-impact global system implementation programs as a consultant, business, or IT lead, and/or business sponsor Direct experience with systems, such as Veeva Vault, ETQ Reliance, Sparta TrackWise, OpenText, SharePoint, Documentum D2, FirstDoc FirstPoint, NextDocs, UL ComplianceWire, and other quality information management or content management systems SaaS/Cloud experience Knowledge of Quality operations within the Life Sciences, Pharmaceutical, Biotech industry, and/or equivalent. Perks & Benefits Flexible PTO Health & wellness programs Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

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 Show more Show less

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities. Vantive: A New Company Built on Our Legacy Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support. Job Summary Job Title – Research Associate III (Testing Coordinator) Location – Whitefield, Bangalore Shift – General This position is responsible for The Testing Coordinator will utilize his/her scientific knowledge to own operational excellence and continuous improvement; This role involves streamline processes; coordinate business, management, and technical SMEs; identify risks; devise solutions, all to support the establishment of Operational excellence. Essential Duties And Responsibilities Provide business and execution leadership for multiple analytical and stability-related projects and holding accountability for testing schedules, risks, and interacts with all functions and levels of management ensuring effective communications. Lead internal initiatives that enhance operational excellence. Interact with platform core team leaders and other key business stakeholders to be able to proactively anticipate business needs. Process inputs from Global Analytical, Stability Functional Leader and Analytical leads and Stability SMEs to determine schedules and forecast resource allocations to projects. Ensuring the availability of all prerequisites for scheduled laboratory analytical and stability testing. Master the planning of activities for testing and ensure on-time completion of all testing activities. Effectively coordinate testing with global teams and CROs as applicable to meet the KPIs on time. Interact with other testing groups (Particle, Sterility/BET, etc.) to determine schedules and alignment with business needs/function commitments. Ensure the maintenance of laboratory compliance as per regulatory requirements. Ensure import licenses are in place and manage laboratory samples inventory. Coordinate with procurement and technical teams for on-time procurement of chemicals and resolution of analytical instrument problems. Coordinate with external and internal sample shipment personnel’s for receiving testing samples on time. Participate in handling of laboratory investigations that correspond to atypical or out-of-specification/out-of-trend test results and other nonconformance records and leverage critical thinking skills to drive the investigation to conclusions based on sound scientific principles and propose appropriate corrective and Preventive root causes. Author/Follow SOPs of relevant procedures. Qualifications Proven experience in stability testing, analytical method validation and transfers, laboratory management, or a similar role. Strong leadership and project management skills. Excellent communication and interpersonal skills. In-depth knowledge of relevant QSRs, GxP, and other regulatory requirements. Handling of software like Trackwise. Proficiency in resource planning and inventory management. Critical thinking and problem-solving skills. Ability to work effectively in cross-functional and global teams. Proactive and able to anticipate business needs and challenges. Basic computer skills (MS Office Word, Excel, PowerPoint, etc.) Education: Master’s in chemistry or Pharmaceuticals, with 6 to 10 years of experience. Education And/or Experience Bachelor’s degree with 8-14 years’ or Master’s degree with 5 to 10 years' of experience in relevant scientific discipline (Analytical chemistry/Pharmaceutical chemistry). Reasonable Accommodation Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link Recruitment Fraud Notice Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. Show more Show less

Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich people’s lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That`s why we are always looking for curious minds that see themselves imagining the unimageable with us. Your Role Work as a team to support Process Solutions organization of Company’s LS to achieve the goal. Process service complaints in Trackwise and ERP. Hands on experience in ERP system SAP, Oracle and CRM tool SFDC. Knowledge of order management process and the concept of creating debit & credit. Partner with team to deliver quality services, enhance operational efficiencies. Process customer documentation requests and Process Leads in SFDC. Contribute to incremental revenue directly or indirectly. Complaint management – Handling service complaints. Create & assign Leads for Sales and Marketing team by critical thinking. Create orders in ERP/other tools for credit, debit, investigation and return and establish the strong follow ups with key partners to close the requests in SFDC. Coordinating with Customer master data team to update customer masters. Process on discrepancy area database request and quality task request in ERP system. Review of errors done by team and giving suggestion to mitigate the future occurrence. Build robust relationship with key partners and stakeholders. Who You Are Any Bachelor’s Degree from recognized university. Preferably with relevant experience in SFDC, SAP. Experience in Order Management / Service Complaints with 1-2 experience is preferred. Should possess basic knowledge of SFDC Functional Knowledge and ERP (SAP& Oracle) User Knowledge. Hands-on experience on ERP’s like SAP, SFDC. What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress! Apply now and become a part of our diverse team! Show more Show less

India - Hyderabad JOB ID: R-214289 LOCATION: India - Hyderabad WORK LOCATION TYPE: On Site DATE POSTED: Apr. 29, 2025 CATEGORY: Quality Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. What you will do Let’s do this. Let’s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management’s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master’s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor’s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in revenue in our last fiscal year with extensive growth potential ahead. At the heart of Veeva are our values: Do the Right Thing, Customer Success, Employee Success, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors. As a Work Anywhere company, we support your flexibility to work from home or in the office, so you can thrive in your ideal environment. Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities. The Role The Migration Consultant will be an important member of the Veeva Systems Professional Services group, implementing migration solutions for our global project teams, which implement Veeva Vault R&D applications and Vault Platform cloud solutions for companies in the life sciences industry. The Migration Consultant will work on customer migration implementations using the best practices and expertise with data and document content migration, Vault API, Vault migration tools, and Vault Platform best practices. Migration Consultant is a customer advocate working closely with other Veeva teams (Services, Product) to ensure customer success today and in the future. This is a remote, full-time, permanent role with Veeva. What You'll Do Contribute to Vault R&D migration implementation, including the migration of document content and object data from legacy systems to Vault Work on Migration Projects from A to Z and support customer Validation exercise Work with Data Migration Leads and Architects on migration activities and best practices Contribute to our knowledge base to build a migration program Develop internal and external tools to help our customers and consultants Requirements 3+ years of direct experience with Veeva Development Cloud applications 3+ years of customer-facing technical consulting experience 3+ years of working experience in implementation or data migration or integration consulting with enterprise software systems (Documentum, Trackwise, Sharepoint, SAP, Salesforce.com, Siebel, Oracle, Argus, ArisGlobal, etc.) Good skills with SQL and databases, REST APIs Strong presentation skills, verbal & written communication skills Experience working in large complex project teams and global clients Strong interpersonal skills Nice to Have Experience with the Pharmaceutical and Life sciences industry Experience with Clinical, Quality, Regulatory, or Safety business processes Background and experience in data migrations or integrations Experience working with ETL tools/products, Python, Java Background with GxP and software validation regulations Background with the migration verification process Perks & Benefits Opportunity for rapid progression in a high-growth business Health & wellness programs Flexible vacation policies 1% charitable giving program Veeva’s headquarters is located in the San Francisco Bay Area with offices in more than 15 countries around the world. Veeva is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin or ancestry, age, disability, marital status, pregnancy, protected veteran status, protected genetic information, political affiliation, or any other characteristics protected by local laws, regulations, or ordinances. Show more Show less

Job Summary We are seeking a Product Analyst with 2 to 5 years of experience to join our team in a hybrid work model. The ideal candidate will have expertise in TW-Basic Config and Trackwise On-prem with a preference for experience in the Medical Devices domain. This role involves analyzing product performance and contributing to product development strategies ensuring alignment with company goals. Responsibilities Analyze product performance data to identify trends and insights that drive product improvements. Collaborate with cross-functional teams to gather and document product requirements. Provide technical expertise in TW-Basic Config and Trackwise On-prem to support product development. Develop and maintain product documentation to ensure clarity and consistency. Conduct market research to understand customer needs and competitive landscape. Assist in the creation of product roadmaps and strategies to align with business objectives. Monitor product lifecycle and recommend enhancements based on user feedback. Support the implementation of product changes and updates to improve user experience. Communicate effectively with stakeholders to ensure alignment on product goals and priorities. Utilize data analytics tools to measure product success and inform decision-making. Ensure compliance with industry standards and regulations particularly in the Medical Devices domain. Participate in product testing and quality assurance to ensure high standards are met. Contribute to the continuous improvement of product management processes. Qualifications Possess strong analytical skills with the ability to interpret complex data sets. Demonstrate proficiency in TW-Basic Config and Trackwise On-prem. Exhibit excellent communication skills in English both written and spoken. Show a keen understanding of the Medical Devices industry is a plus. Display the ability to work collaboratively in a hybrid work environment. Have a proactive approach to problem-solving and decision-making. Maintain a customer-focused mindset to enhance product offerings. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

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 –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 Computer System Validation and stakeholder management 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 Actively contribute to the IT applications project management initiatives that includes Validation activities as per GAMP Life Cycle approach Integrate technology with business process transformation programs like SAP, LIMS, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. Troubleshoot IT application related issues and suggest recommendations for solutions in consultation with relevant functions. Perform Gap assessment and Remediation procedures for legacy applications to ensure validation policies is in line with Life Cycle Approach Perform Software classification, IT risk assessment and Mitigation strategies for IT applications. Provide guidance and share knowledge and participate in performing procedures focusing on complex, or specialized issues in a regulatory environment. Work with the client to create plans for accomplishing engagement objectives and a strategy that complies with professional standards and addresses the risks inherent in the engagement Assist Senior Managers in driving the business development process on existing client engagements by associating with clients and executing the deliverables in the most efficient manner. Create innovative insights for clients, adapts methods & practices to fit operational team needs & contributes to thought leadership documents. Demonstrate team work 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 Prior experience of leading quality and compliance projects in Regulatory Compliance. Good understanding of regulations such as USFDA, WHO, HIPAA, TGA, MCC, Anvisa etc. Well versed with ICH guidelines, ISPE framework on Risk management, and SDLC Strong Knowledge on Enterprise IT applications like LIMS, SAP, ELN, MES, Documentum, TrackWise, Veeva Vault, ValGenesis, Argus, Regulatory Information Management System etc. in Pharmaceutical organization Proficient in SOP documentation, drafting work instructions/user manuals, authoring and review of Validation Deliverables such as Validation Plan & report, Requirement specifications, Risk Analysis, Qualification Protocols & reports, Test Scripts, Traceability Matrix etc. Demonstrated track record in project management, governance, and reporting Good understanding of Quality System Elements such as, Deviation, CAPA, and Change Controls etc. Exposure to Data Integrity requirements and other applicable regulations Knowledge of Incident Management, Change Management, Periodic Review, Vendor Management, Quality Management Review procedures Prior experience of supporting Audits / Inspections Sound domain knowledge in Pharmaceutical industry in the areas of Quality control, Quality assurance Strong knowledge of Computerized Systems validation concepts such as GAMP 5 - A Risk-Based Approach to Compliant GxP Computerized Systems Hands on experience of preparing validation deliverables for software implementation projects Sound understanding of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11, To qualify for the role, you must have B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Postgraduate in Science (Preferably in Chemistry/Biochemistry) with 5-8 years of experience with Big 4 or Multi-National Regulatory Compliance companies Good interpersonal skills; Good written and presentational skills Ideally, you’ll also have Certified Software Quality Engineer (CSQE), Certified Software Quality Assurance (CSQA) ISO 9001:2015 Lead Auditor, Quality Auditor Certification (CQA) Information Security or Risk Management certifications 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. Show more Show less

Be the First to Apply Job Description Business: PPL Digwal Department: TSD Location: Digwal Job Overview: To perform Production actives as per GMP & Safety Travel Requirements : NA Reporting Structure Reports to Manager - TSD Key Stakeholders Internal: QC, QA, SCM & Safety External: NA Experience 6-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities Key Roles & Responsibilities Initiation of change controls Prepare the new BMRs, BPRs & ECRs as per requirement. Revision of existing BMRs, BPRs and ECRs as per requirement. Monitor & close the CAPAs. To plan the daily activities in the concerned production blocks. Close the pre- action & post- actions related to change controls in trackwise. Initiation and of review of deviation and investigation reports. Review the executed BMRs, BPRs, ECRs etc. Indenting & receiving of new / executed BMRs, BPRs, ECRs etc. Provide the response to the internal / external parties comments & update the documents. Follow the safety precautions. Maintain discipline at the work place. Ensure effective implementation of the cGMP compliance and quality management system in the plant. Follow the cGMP system and provide the training on change documents, SOP, CAPAs related to investigations, deviation etc. as per requirement. Any other responsibilities assigned from time to time as per requirement. Qualifications Qualification : B.Sc (Chemistry) / M.Sc (Chemistry) / B.Tech (Chemical) Job Info Job Identification 5344 Posting Date 05/28/2025, 09:16 AM Apply Before 05/30/2025, 09:16 AM Degree Level Technical Diploma/A Level Job Schedule Full time Locations Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN Show more Show less