Manager External Supply Quality - QMS

Basic Requirements:
\n Education: Post-Graduate in Science / Pharmacy discipline.
\n Experience: Preferably 10 plus years experience in Quality Control activities and Quality Assurance in Quality Management Systems.
\n Special Knowledge: Good Knowledge of Analytical, Documentation / Regulatory requirements & Quality Management Systems.
\n Effective verbal and communication skills, collaborative team member & team leader.
\n Capable to work independently & efficiently.
\n Business understanding: Understanding the pharmaceutical industry. The key responsibilities of this role are mainly:
\n Specification Management
\n - Review, Revision, and Issuance of FPS / RMS / IMS / PMS related to LL products.
\n - Ensure Specifications are aligned to Pharmacopoeia requirements all the time.
\n - Ensure Regulatory specifications are updated & provide timely support for regulatory requests.
\n - Maintain Specifications throughout their life cycle.
\n Pharmacopoeia Compliance
\n - 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.
\n - Track and evaluate the draft proposals for comments in applicable pharmacopoeia for relevant changes & coordinate with Regulatory/PIAG team on these aspects.
\n Oversight for approved Public Testing laboratories of ES India Rx
\n -
\n Stability Studies
\n - Tracking of stability study testing of ES products on monthly basis.
\n - Review of stability report for any significant change for ES products.
\n - Escalation of significant change to relevant Governance forums.
\n - Stability data evaluation to support extension / restoration of shelf-life for ES products.
\n Periodic Product Review
\n - Tracking of CMOs PPR & identified review actions for completion.
\n - Review of PPR and executive summary report.
\n - Updates and Escalations related to PPR process in relevant Governance forums.
\n QRI coordinator
\n - To ensure, all the relevant QRI communications are evaluated in coordination with sites for applicability & perform business impact assessment, if applicable.
\n - Coordinate with respect stakeholder for ensuring implementation of the QRI requirements.
\n Quality Agreement Coordinator
\n - Prepare / Revise Quality Agreements with CMOs.
\n - Prepare Amendments to the Quality Agreement for change in the responsibility or other details.
\n Other responsibilities-
\n - 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.
\n - To ensure the SOPs of relevant profiles are revised as per need or routine revision.
\n - To ensure the responsibilities and tasks mentioned in the IPTc are completed.
\n - To conduct MM/IBM audits within External Supply India Rx.
\n - To ensure QMS actions related to profile are raised and completed on time.
\n - To ensure all time inspection readiness for above mentioned profiles.
\n - To carry out annual reviews of the processes to identify improvement opportunities.
\n - To identify and log the risks in RMS for risks foreseen relevant to the assigned profile.
\n - To act as backup for performing the activities under other profiles, as needed.
\n - Any additional activities assigned by the Line manager as and when required.