QA

B.Pharm or Graduation in Biomedical Sciences. Minimum 3 years experience for Operations Manager and 1 year experience for Associate Manager in pharmaceutical / medical device regulatory affairs.

Responsible for execution and review support of Quality Assurance activities including document review, shop-floor QA support, deviation handling, and quality systems support to ensure compliance with cGMP and regulatory requirements.

M.Pharm with 8-12 Yrs experience Ph.D in Pharmaceutics with 5-10 Yrs Experience

Strong knowledge of Quality Agreement / Technical Agreement drafting and review. Practical experience in vendor risk assessment, approved vendor list management and periodic vendor requalification.

Knowledge of Injectable plant in Validation of injection filing line, Lyo, Autoclave, DHS etc & Knowledge of QMS 

Review and approval of analytical documents, raw data, audit trails, calibration/PM records, analyst qualification documents, and reference/working standard qualification records in compliance with GMP and data integrity requirements.

Support system implementation, upgrades, and change management. Work with clients and crosse Functional teams to ensure regulatory compliance 

Candidate should have knowledge of IPQA, Validation, QMS. Responsible to adherence cGMP guidelines