Executive - Quality Assurance, Pharma

16 hours ago

Ankleshwar, India Zentiva Group, a.s. Full time

Job title: Executive - Quality Assurance, Pharma

Educational Qualification
- B. Pharm / M. Pharm from a reputed university

Experience
- 2 to 5 years of similar experience in regulatory-approved OSD manufacturing large units.

Quality Management/Continuous Improvement
- Line Clearance and shop floor compliance
- In-process checks and sampling activity
- Assisting in the Complaint Investigation system at the site
- Assisting in Qualification and validation system, change control system, deviations
- Preparing & reviewing the Annual Product Quality Review
- Review of Batch Manufacturing & Packing Records
- Coordination of cGMP Training activity.

Documentation Control:

- Preparation of quality system SOPs
- Controlled distribution and archival of documents & record
- Control of master documents
- Management of archival room
- Issuance of batch records, ATR, logbooks, and controlled formats.

Assuring the Quality of products by:

- In process controls
- Review of Executed Batch Manufacturing & Packing Records
- Ensuring implementation of Corrective actions/Preventive actions proposed in Deviations and Customer complaints
- Ensuring the effectiveness review of the implemented CAPA
- Review of batch records & analytical testing records

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