About the Job
Position: Manager/Sr. Manager Quality Control
Company: Ipca Laboratories Limited
Location: Tarapur, Palghar, Maharashtra, India (On-site)
Employment Type: Full-time
Level: Mid-Senior level
Industry: Pharmaceutical Manufacturing
Number of Employees: 10,001+
Applicants: Over 100
Reposted: 3 weeks ago
Qualification
- Degree: B Sc / M Sc
Experience
- Years of Experience: 18 – 22 years
Key Responsibilities
| Responsibility | Description |
|---|---|
| cGMP and GLP Monitoring | Oversee all cGMP and GLP activities in the laboratory. |
| QC Activity Planning | Daily planning and review of analytical raw data. Approve and reject raw materials, finished products, and packing materials. |
| Sampling and Testing | Ensure sampling and testing of raw materials, in-process, finished products, process validation, hold time analysis, stability samples, and packing materials as per procedure. |
| Documentation Review | Review specifications, test procedures, and SOPs. |
| Analytical Method Transfer | Review analytical method transfer and process validation documents. |
| Incident Handling | Ensure timely handling and closure of incidents, deviations, and change controls. |
| Investigation | Investigate and close OOS, OOT, and market complaints timely. |
| Standards Management | Manage working standards, reference standards, and HPLC column management. |
| Instrument Maintenance | Ensure instruments are periodically calibrated and maintained as per schedule. |
| Audit Handling | Manage internal, external, and regulatory audits. |
| Contract Laboratory Monitoring | Monitor samples for contract laboratory analysis. |
| Calibration Record Review | Review and approve calibration records of analytical instruments. |