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Post : Assistant Manager - Q&C
Job Description
To ensure compliance of External Manufacturing sites in India to applicable regulations, corporate quality guidelines, standards and procedures.
Key Responsibilities:
- Responsible for assigned India EM (External manufacturer) product quality and release operation.
- Support execution of new/current EM GMP qualification regular audit/assessment from external and internal parties and AAP (Audit Action Plan) follow-ups.
- Lead Quality meetings with EM management team
- Execute GMP/Quality improvement initiatives at EM sites (e.g., Zero Defect Program, Mix-up prevention, Micro design robustness etc.,)
- Ensure that every EM has established and effectively maintained quality management system and quality practices that meet J&J requirements.
- Review and periodically monitor manufacturing processes at EM site for improvements and compliance enhancement
- Co-ordinate the investigation of non-conformance, evaluate casual drivers and determine CAPA actions. Participate in final investigation decision for non-conforming materials / products.
- Support complaint handling investigation process and timely response in co-ordination with EM.
- Conduct GMP audit and Microbial risk assessment at EM sites
- Represent EM QA in NPI (New product introduction) cross-functional team. Ensure flawless execution of new product launches.
- Review specifications for new products/processes and RM/PM specifications
- Participate in development of protocols and shop-floor execution of process qualification, C&S validations and APR (Authorization of product release) for new/modified products
Qualification:
Bachelor in Pharmacy/ Master of Science
Knowledge of cGMP, Local Regulations and Quality Systems and Guidelines. Leadership, collaboration and interpersonal skills
Analytical and process oriented , Knowledge of International regulations (US FDA, TGA, etc.)
Additional Information:
Qualification: B.Pharm, M.Sc
Location: Maharashtra-Greater Mumbai
Functional Area: Q&C
Industry Type: Pharma/Biotech/Clinical Research
End Date: 20th July, 2017
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