Posted 1 month ago
Manager- Integrated Quality & Compliance Lead (Injectable)
AI Summary
Manages integrated quality and compliance for injectable products at a CDMO, reviewing documents, supporting the QMS, performing risk and trend analysis, managing supplier lists, and assisting with electronic quality systems.
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Division
Piramal Pharma SolutionsPiramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.
This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.
Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.
For more details, please visit : www.piramalpharmasolutions.com
Job Title
Manager- Quality (DDRC)Job Description
Integrated Quality & Compliance Lead (Injectable)1) Document Review & QMS Support:
- Review and approve protocols, SOPs, and provide support to the Quality Management System (QMS)
2) SME QA Support:
- Provide subject matter expert (SME) QA support during night shifts
3) Risk & Trend Analysis:
- Perform trend analysis and conduct risk assessments to support quality improvements
4) Supplier Management:
- Manage and maintain the Approved Supplier List (ASL)
5) Electronic Quality Systems:
- Provide support for electronic quality systems to ensure smooth operations and compliance
Skills
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