Manager External Supply Quality QMS

Basic Requirements:
Education: Post-Graduate in Science / Pharmacy discipline.
Experience: Preferably 10 plus years experience in Quality Control activities and Quality Assurance in Quality Management Systems.
Special Knowledge: Good Knowledge of Analytical Documentation / Regulatory requirements & Quality Management Systems.
Effective verbal and communication skills collaborative team member & team leader.
Capable to work independently & efficiently.
Business understanding: Understanding the pharmaceutical industry. The key responsibilities of this role are mainly:
Specification Management
- Review Revision and Issuance of FPS / RMS / IMS / PMS related to LL products.
- Ensure Specifications are aligned to Pharmacopoeia requirements all the time.
- Ensure Regulatory specifications are updated & provide timely support for regulatory requests.
- Maintain Specifications throughout their life cycle.

Pharmacopoeia Compliance
- Track and implement pharmacopoeia changes on routine basis and as & when changes are notified by relevant pharmacopoeia to ensure 100% adherence to pharmacopoeia requirements before the effective date.
- Track and evaluate the draft proposals for comments in applicable pharmacopoeia for relevant changes & coordinate with Regulatory/PIAG team on these aspects.

Oversight for approved Public Testing laboratories of ES India Rx
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Stability Studies
- Tracking of stability study testing of ES products on monthly basis.
- Review of stability report for any significant change for ES products.
- Escalation of significant change to relevant Governance forums.
- Stability data evaluation to support extension / restoration of shelf-life for ES products.

Periodic Product Review
- Tracking of CMOs PPR & identified review actions for completion.
- Review of PPR and executive summary report.
- Updates and Escalations related to PPR process in relevant Governance forums.

QRI coordinator
- To ensure all the relevant QRI communications are evaluated in coordination with sites for applicability & perform business impact assessment if applicable.
- Coordinate with respect stakeholder for ensuring implementation of the QRI requirements.

Quality Agreement Coordinator
- Prepare / Revise Quality Agreements with CMOs.
- Prepare Amendments to the Quality Agreement for change in the responsibility or other details.

Other responsibilities-
- To ensure all the KPI targets for relevant profiles are achieved and provide the relevant data/updates in this regard to ES Quality council and other forums.
- To ensure the SOPs of relevant profiles are revised as per need or routine revision.
- To ensure the responsibilities and tasks mentioned in the IPTc are completed.
- To conduct MM/IBM audits within External Supply India Rx.
- To ensure QMS actions related to profile are raised and completed on time.
- To ensure all time inspection readiness for above mentioned profiles.
- To carry out annual reviews of the processes to identify improvement opportunities.
- To identify and log the risks in RMS for risks foreseen relevant to the assigned profile.
- To act as backup for performing the activities under other profiles as needed.
- Any additional activities assigned by the Line manager as and when required.