QA Reviewer

1 week ago

Moraiya Ahmedabad Gujarat, India Zydus Group Full time

Department
- MORAIYA QA
- Job posted on
- Mar 03, 2025
- Employment type
- P-P8-Probationer-HO Executive

1. Monitoring of cGMP compliance in all laboratories In process, Finished Product, Raw Material, Packaging Material, Stability, Method Validation, as per Document control procedure

2. Review and Approval of the all laboratories related analytical data as per the scope of SOP including the investigations.

3. Review and Approval of In process, Finished Product, Raw Material, Packaging Material, Stability, Method Validation, Method Transfer, GLP, Market Complaints ,Cleaning Validation, Cleaning-Swab Rinse, Engineering Batches Protocols, Reports, Qualifications documents, CoA, Split requests, Summary Sheets, Stability Chamber Data and Responsible for approval in LIMS, SAP, Trackwise, etc.

4. Review and Approving of Analyst Qualification, Reviewer Qualification data.

5. Daily monitoring of lab activities, recording of observations. Preparing, reviewing related trends of Oversight and Review.

6. Issuance of Laboratory Log books, Registers.Protocols, Report No., OOC No., etc.

7. Review and Approval of 2-Ply Verifications, Code to Code transfers, System Audit Trails, spread sheet validation, Preventive Maintenance and External Calibrations in SAP.

8. Perform the SOP based roles in TW, D2, LIMS, ZYTIMS, ZYUAMS, SAP, all lab softwares SAP related activities

9. Review and Approval of SOP, OOS, OOT, Incidents, Deviations, Change Controls, CAPA, OOC, investigations, data, trends, etc.

10. Monitoring of Hypothesis /extended study of laboratory investigation.

11. To monitor document destruction in bin.

12. Review of reduced/skip testing reports for raw material and packaging material and In process stage.

13. Preparation of Quality event alert notification, Quality index data of incident event for TRM.

14. To resolve & rectify the issuance raised by the employees of the department related to the process, Product, Quality, Cleaning process or documentation and applicable events handled through QMS.

15. To resolve and escalate any failures and overdue activity that can have a potential impact on product quality.

**Job Details**:
Role: QA In QC

Position: Senior Executive/Assistant Manager/Deputy Manager

Report to: Senior Manager

Department: Quality Assurance

Location: Moraiya

**Requirements**:
Year of Experience: 07-12 years

Experience in Zydus: 24 months

**Qualification**:
M. Sc.(Chemistry field) or B. Pharma

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