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Manager External Supply Quality - QMS
ScaleneWorksBengaluru, karnataka, India30+ days ago
Job type
- Quick Apply
Job descriptionTrack 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. 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. 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. 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. Prepare / Revise Quality Agreements with CMOs. Prepare Amendments to the Quality Agreement for change in the responsibility or other details. 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.
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
Oversight for approved Public Testing laboratories of ES India Rx
Stability Studies
Periodic Product Review
QRI coordinator
Quality Agreement Coordinator
Other responsibilities-
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Manager Quality • Bengaluru, karnataka, India
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