Quality engineer- Pharma API industry

1 month ago

Bangalore Rural, India Infinitalent Consulting (P) Ltd Full time

Work Location: Doddaballapura, Bangalore

Designation: Quality engineer

Experience required : 2 to 3 years

Industry Type: Pharma API industry

Salary Range : 4 to 5 LPA


1. Handling quality events in production department. i.e., Change Control, Deviation, OOS, OOT, CAPA and investigation.

2. Preparation of Equipment Performance qualification protocol and report.

3. Provide data to QA to prepare Process Validation Protocol and report.

4. Preparation of Batch Manufacturing Record (BMR), Master Formula Record (MFR) and Standard Operating Procedures (SOP) related to Production department.

5. Coordinate the preparation, review, approval, and distribution of production-related documents, including BMRs, SOPs, investigation reports, and Change control forms.

6. Train production staff on SOP, BMR, CAPA and proper documentation practices.

7. Collaborate with cross functional teams such as R&D, QC, QA, Maintenance, stores and Commercial for data collection and document review. Participate in quality reviews and investigations as needed.

8. Support internal and external audits and inspections by preparing documentation, facilitating document retrieval, and addressing auditor inquiries.

9. Maintain the storage, retrieval, and archival of production documentation. Ensure documents are stored securely and are readily accessible for audits, inspections, and other quality assurance activities.

10. Review of Batch manufacturing record & batch packing record for completeness weekly basis.

11. Review of production log books like equipments usage log book, Clean room usage log book, weighing balance Performance log books and Daily Humidity recording log book.

12. Co-ordination with external agency for calibration of Production department Temperature and relative humidity instruments, weighing balances and standard weights.

13. Taking line clearance for clean room from QA for product change over.

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