QA

1. Check and approve packaging requirements of products and materials according to regulatory requirements.

2. Full review of batch records to ensure compliance per the repackaging instruction and GMP standards.

3. Verify correct execution of batch process activity against approved / updated BMR

4. Perform required In-Process quality checks and create quality inspection log.

5. Record Inspection Results and Issue necessary documents to facilitate release.

6. Liaise with QC Executive to ensure timely release of goods, QA checks or perform final sign-off of repackaged goods release after all releases have taken place.

7. Authorized to stop any packaging activity, when necessary.

8. Giving clearance for processing after quality inspection.

9. Updating of QA activity such as batch record trackers as required. Perform QA sampling, inspection and release of materials.

10. Checking and approving over printing instructions.

11. Updating of logs and trackers as required.

12. Ensure general cleanliness and hygienic conditions of each workstation.

13. Ensure compliance to ISO procedures, GXP and regulatory requirements.

14. Work closely with inter-departmental personnel to ensure quality is maintained throughout the organization.

15. Participate in internal audits, training, and general communication to achieve and sustain a high level of quality performance throughout the organization

16. Support quality administrative function when necessary.

17. Ensure all repackaging activities are carried out in accordance with authorized specifications and that quality checks are performed throughout the process in a stringent and effective manner.

18. Continuous improvement etc i.e., implement / participate in continuous improvement / project / training / presentation.

19. Responsible for coordinating during the audit time of regulatory bodies,

customer audits and internal audits.

20. Acting and ensure Internal audit performance without any non-conformities.

21. Client and Regulatory audit performance without any non-conformities

22. Taking informed decision in shifts and acting on behalf of Quality assurance in-Charge.

23. Quality Management System Maintenance as per compliance requirements.

24. Whenever required testing in quality control Lab and ensure records and maintained properly.

25. Issuance of control copies and maintain records.

26. Any other job assigned by HOD/ Management.

v **Regulatory Audits and Compliances**:
Ø Key role in Audit handling and coordinating with documents requirement.

Ø Proactive instructions to concern department regarding auditors’ requirements and approach.

Ø Explaining the auditors about the Quality systems, Qualification documents (PV), Stability study & SOP’s of organization.

v **Quality Management Systems**:
Ø Handling of Quality Management Systems (Change controls, Deviations, Incidents & Market Complaints).

Ø Responsible for investigations of market complaints and evaluation of CAPA from time to time. Response to market complaints with detailed investigation reports using Qualitative tools.

Ø Responsible for investigation of Non-Conformance's.

Ø Trending of QMS & Evaluation.

v Documentation Related:
Ø Preparation of Standard operating procedure(SOP), Review, distribution and control of formulation technology transfer data and Documents pertaining routine procedures.

Ø Verification of Artworks and its approvals.

Ø Conducting internal audits and preparation of internal Audit reports.

Ø Controlling of Master Documents (Like Specifications, STP, SOP’s, MFR’s, BMR’s, BPR’s, Manuals etc.)

v Vendor Qualifications:
Ø Review of Vendor Qualification documents & Performing of Vendor Audits.

Ø Preparation of Vendor qualifications audit reports and Approval of Vendors of API & Packaging materials.

Ø _**Quality Management Systems**_

Ø _**Incidents**_

Ø _**Deviations**_

Ø _**Change controls**_

Ø _**Regulatory Audits & Compliances**_

Ø _**Root cause Analysis**_

Ø _**Vendor Qualification**_

Ø _**Documentation**_

Ø _**Training & Knowledge Sharing**_

Ø _**Cleaning Validation **_

Ø _**Licensing**_

**Salary**: From ₹25,000.00 per year

**Benefits**:

- Food provided
- Health insurance

Schedule:

- Day shift
- Morning shift
- Night shift
- Rotational shift

**Education**:

- Bachelor's (preferred)

**Experience**:

- total work: 3 years (preferred)

Work Location: In person

**Speak with the employer**

+91 8925849563