Manager External Supply Quality

Job description

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 • Assist the Product Incident Chair in raising the product incident, uploading product incident minutes of meeting and associated documents, initiating the GRB process in PRS and organizing meetings. • To support Product Incident Chair in closure of product incidents in PRS and retaining all primary documentation in share drive database. • To track the performance of Product Incident process and escalate the risks if any to ES Quality Council. • Carry out an annual review of the process so that it continues to be effective and to identify opportunities for further improvement 4. Management of communications received from various state &/central regulatory authorities at CMO sites/GSK. • Co-ordination and review of various regulatory communications received at contract manufacturing sites with necessary inputs. Ensure timely response is submitted. • Provide necessary support & inputs from GSK to CMO sites for responding to regulatory communications/notifications. • Governance & tracking of regulatory communications received at various CMO sites. • Liaising with regulatory authorities as and when required. • Provide regular updates on above to the Tier meetings & governance forums. 5. QMS Implementation coordinator • Review the changes in the QMS and assess its applicability to ES India Rx. • Ensure timely completion of Gap assessments & Impact assessment of QMS updates to ES India. Timely inputs to wider review assessments. • Ensure timely implementation & review of draft proposals of the QMS updates from SMEs. • Timely escalations (if any) in relevant governance forums QMS Implementation front. 6. Other • To perform the QMS gap assessment for the relevant systems and comply with the requirements. • To ensure SOPs of relevant profiles are revised as per need or routine revision. • 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 provide support to QMS Lead by preparing and consolidating ES Dashboard and slide pack for ES Quality Council, Regional Quality Council and other management meetings. • To act as Data Integrity Champion for External Supply India. • To ensure all-time audit/ inspection readiness for above mentioned job profile. • To identify and log the risks in Risk Management System for any risks foreseen relevant to the assigned profile. • To conduct internal audits/self-inspection for ES Rx India. • To act as backup for performing the activities under other profiles whenever the respective profile owners are on leave and ensure any additional activity assigned by the line manager as and when required. Basic Qualifications: • Graduate in Science/Pharmacy, with a postgraduate qualification preferred. • Area of Specialization: Broad and thorough technical and regulatory knowledge of current pharmaceutical manufacturing and analytical techniques/ processes. • Preferably 7 plus years of experience in Quality Assurance in Pharmaceutical formulations. Experience of dealing with various state drug regulatory authorities. • Having 5 years of experience in the handling of market complaints, Deviations and CAPA management