Job Description

Sub Function/POD
SEZ PLANT II
Job posted on
Jan 03, 2026
Employee Type
P-P7-Probationer-HO Staff
Experience range (Years)
7 years - 15 years

Role - Validation & Qualification lead Designation -Deputy Manager to Manager Reporting to - Site QA Head Department - QA BU - Technical Services Plant - SEZ - 3, Ahmedabad

Role -

Person would be working as a Team Leader role; leading validation & qualification activates of the new OSD green project.

Person should have strong background in working with USFDA Green-Field OSD manufacturing facility and projects from the initial stage right after procurement of machines and equipment. Good to have experience and understanding on the VSU - Vertical Start-Up concepts and methodology.

Responsibilities -

1. To lead, administratively and functionally, Validation Section (Process Validation, Cleaning Validation, Equipment / Facility / Utility Qualification and Computer System Validation)
2. To assign job responsibilities and ensure training for the Validation and Qualification QA employees.
3. To ensure availability of sufficient resources in Validation and Qualification as per the requirements.
4. To lead Validation QA in internal and external audits and to ensure compliance response to the audit observations.
5. To ensure enhancement of systems at site as per the cGMP requirements and in alignment with CQA policies and guidelines.
6. To prepare & provide data related to validation function for Quality Index / Quality Matrix of the site.
7. To ensure that the Validations and Qualifications are done as per the validation master plan and schedule.
8. To review the Site Master File and Validation Master Plan.
9. To review the Standard Operating Procedures pertaining to Validation and other departments.
10. To review and approve Change Control Proposals, Deviations and Investigation related to manufacturing, systems, operations, facility, equipment and documents.
11. To review and approve the Risk Assessment and mitigation plan wherever required.
12. Analyze data on effectiveness of the QMS and evaluate continual improvement of the QMS.
13. To review Technology transfer documents & protocols / reports associated to engineering batch activities.
14. Responsible for Review and Approval of Process Validation, Cleaning Validation, Hold Time Study, Facility & Utility system Qualification Protocols and Reports.
15. Responsible for Review and approval of Engineering department documents i.e. Layouts, RDS, Room Book and Planners.
16. Responsible for Review and approval of any discrepancy, addendum and justification of qualification and validation activities.
17. Imparting training of SOP's for Qualification / Validation
18. Responsible for Review and Approval of re-qualification / periodic re-qualification and thermal mapping protocol and report.
19. Responsible for Review and Approval of Equipment Qualification (URS, SIA, CCA, RA, URS traceability matrix, DQ, IQ, OQ, PQ, RQ, Thermal Mapping etc.) Protocol and report.
20. Responsible for Review and Approval of CSV / PLC Validation Protocols and Reports for Applications and Equipment.
21. Responsible for Quality Assurance activities & ensure cGMP compliance in Information Technology department.
22. Responsible for Review and Approval of documents of Information Technology department
23. Responsible for Handling of Deviation, CAPA, RCA, CC related to Qualification and validation.
24. To perform Self-Inspection (As applicable) & facilitate Self- Inspection