Batch Certification Lead

Job Role : Batch Certification Lead

Grade : DGM

Location - Dadra (OSD Formulation USFDA site)

POSITION SUMMARY

Responsible for certification of batches manufactured at applicable site for US/Canada commercial distribution. Manage overall batch certification oversight of site QA activities related to manufacturing batch records, packaging records, QC lab records, certificates of analysis/compliance and all related supporting documentation (i.e. documentation review, SOP compliance, laboratory application data reviews, batch release, equipment/ instrument preventive maintenance/ calibration/ qualification/ validation as per good manufacturing practices/ good documentation requirements and ALCOA++ principles).

The incumbent will assure individual compliance with the all concerned regulatory requirements, GxP’s and applicable department programs, including training, documentation, Standard Operating Procedures, and Sun Pharma Global Quality Policies, Standards and Procedures.

Key responsibilities:

1. Ensure compliance to regulatory requirements on product, process, equipment and release procedures.

2. Manage Batch certification activities related to commercial dispatch in a timely manner.

3. Escalate compliance concern to concern stakeholder.

4. Review, compliance of BPR and batch release for commercial dispatch.

5. Review and approve all deviations and OOS/OOT investigations

6. Execute change control and risk assessment whenever required.

7. Ensure Quality Metrics are reported as per specify timeline.

8. Planning and arranging for internal and external departmental support of Quality Assurance activities as directed in approved protocols, quality systems or Procedures.

9. Follow the EHS policy, laboratory standard operating procedures and maintain the compliance to GMP requirements.

Educational Qualification : B.Pharm / M.Pharm

Exp - 17+ Years