ata-pm-slice="1 1 []">Piramal Manager Quality (DDRC) Job- Mumbai, Maharashtra, India
Looking to advance your career in pharmaceutical quality management? Piramal Pharma Solutions is hiring a Manager – Quality (DDRC) in Mumbai. This role involves remote support for PPL sites, ensuring regulatory compliance, and managing analytical data. If you have expertise in laboratory software, regulatory requirements, and data integrity, apply now for this exciting opportunity
Job Info
- Business: Piramal Pharma Solutions
- Department: Quality
- Job Identification: 7698
- Job Category: Quality
- Job Schedule: Full-time
- Location: Project: Piramal Agastya, PRL Agastya Pvt Ltd., LBS Marg, Kamani Junction, Mumbai, Maharashtra, 400070, India
- Site Quality Team (QC, QA)
- Corporate Functions
External:
- Regulators (during inspection)
- Solution Providers
- B. Pharm / M. Pharm / M.Sc. Chemistry / B.Sc. Chemistry or equivalent/Microbiology
- Must embody and embrace Piramal values.
- Quality professional with 8+ years of QC/QA experience in regulated pharma companies.
- Hands-on experience in laboratory software, testing, applications, and systems (HPLC, GC, UV, IR, Dissolution, Malvern, KF auto titrator, etc.).
- Experience with LIMS for data entry/master build and data review.
- Knowledge of regulatory requirements (USFDA, EU, Health Canada, etc.).
- Awareness of latest regulations and pharmacopeial requirements.
- Strong verbal and written communication skills, collaboration skills, and team-oriented approach.
- Preparation of Master Build in LIMS.
- Oversee Trackwise operations for QMS activities.
- Preparation and review of Method Validation, Transfer, Verification, and Equivalency documents.
- Preparation and review of Test Methods, STPs, and Specifications.
- Operational knowledge of eDMS and Ensuring application compliance.
- Monitor compendial changes and prepare evaluation reports.
- Review analytical data, raw data, chromatography, and LIMS for RM/PM/FP.
- Prepare and review new SOPs.
- Ensure timely completion of documentation.
- Maintain data integrity in document preparation and review.
- Collaborate effectively across Piramal Plants.
- Provide support to PPL sites as required, including potential travel (India and overseas) for up to 3 months.
- Perform additional tasks assigned by the leadership team.
About Us: Piramal Group has pursued both organic and inorganic growth for over three decades. Rooted in its core values, the organization remains committed to ethical and inclusive growth while maintaining the highest industry standards.
Equal Employment Opportunity: Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based on race, ethnicity, religion, gender, age, disability, or any legally protected characteristics. Our employment decisions are based on merit, skills, and performance, ensuring fair opportunities for all candidates.
About the Team: Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) providing end-to-end pharmaceutical development and manufacturing solutions. Our globally integrated network across North America, Europe, and Asia supports drug discovery, process development, clinical trial supplies, and commercial production. We specialize in highly potent APIs, sterile fill/finish, biologics, vaccines, gene therapies, and monoclonal antibodies, making us the preferred partner for global innovators and generic companies.
