Assistant Manager
1 day ago
Role & responsibilities
- Oversee implementation and adherence to CGMP and quality management systems (QMS) across departments.
- Review and approve batch manufacturing records (BMR), batch packaging records (BPR), and standard operating procedures (SOPs).
- Handle deviations, change controls, CAPA, OOS/OOT investigations**, and ensure timely closure as per internal SOPs.
- Coordinate with cross-functional teams (Production, QC, Regulatory, Engineering) to maintain quality compliance.
- Participate in internal and external audits, including regulatory inspections.
- Monitor and support activities related to validation and qualification.
- Conduct periodic GMP training and awareness programs for plant staff.
- Ensure documentation control, data integrity, and compliance with applicable regulatory standards.
- Assist in vendor qualification, raw material specifications review, and quality risk management.
- Prepare and submit quality reports, audit responses, and periodic reviews to senior QA management.
Candidate profile
- Bachelor's or Masters degree in Pharmacy, Chemistry, or related field.
- 8 - 12 years of experience in QA in the pharmaceutical industry.
- Sound knowledge of GMP guidelines, and pharmaceutical regulatory requirements.
- Strong analytical thinking, attention to detail, and decision-making skills.
- Proficient in documentation, MS Office, and audit compliance tools
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