Job Title - Manager External Supply Quality
Job Purpose:
To provide support on quality and compliance front for contract manufacturing sites (CMOs) as a complaint, deviation & CAPA co-coordinator.
To ensure proper functioning and management of Product Incidents.
To provide quality support to all external supply functions as a Deviation Champion.
To provide support to the External Supply (ES) India Rx functions as Data Integrity Champion.
Management of communications received from various state &/central regulatory authorities at CMO sites/GSK.
QMS Implementation coordinator for ES India.
Key Responsibilities:
The key responsibilities of this role are mainly:
1. Complaint Coordinator
In the event of any complaint received, intimation must be sent to the manufacturing site with respect to complaints received.
To provide support to the investigation into the complaint carried out by the team in the manufacturing plant,
to ensure that the complaint sample is provided to the manufacturing site on time and availability of any other additional information needed by the CMO for further investigation.
Ensure that any critical issues get escalated at appropriate escalation level. To ensure required investigation is completed and CAPA is implemented on time; track the timely closure of complaints.
Report Complaint KPIs to ES Quality Council/ Governance Forums.
Carry out an annual review of the process so that it continues to be effective and to identify opportunities for further improvement.
2. Deviation Champion
To track and monitor all the deviations of entire ES functions for timely closure.
Escalate critical deviations and any overdue situations in deviation closure at Quality Council or ES governance forums.
Periodic review of deviations.
Report Deviation KPIs to ES Quality Council/ Governance Board.
Carry out an annual review of the process so that it continues to be effective and to identify opportunities for further improvement.
3. Product Incident Coordinator
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