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Our goal is to be one of the world’s most innovative, best performing, and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences, and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good, and keep growing.
Position: Executive – External Supply Quality
Location: Worli, Mumbai, Maharashtra, India
Job Purpose :
- To ensure support to business by management of Raw and Packaging material supplier management.
- To support resolution of supplier related complaints by acting as interface between procurement, site Q representatives and Supplier Quality Ops.
- To support Business in introducing new vendors (API, Excipients & Primary packing materials) and coordinating for validations and stability strategies through change management process.
- To Provide support to CMO sites with respect to Microbial method.
- To support Analytical method, transfer w.r.t Microbial method at new/existing sites to support Product transfers.
- To support MERPs team, For implementation of MERPs process.
The Key responsibilities of this role are as follows:
• To ensure that the RM, PM used for manufacturing GSK products are only obtained from GSK approved manufacturers and suppliers.
• Preparation of Approved Supplier list on timely basis and updating as and when required.
• To prepare adequate Risk Assessment / STP for usage / discontinuation of material from disapproved and conditionally approved supplier.
• To provide information to CMOs and site representatives about usage or discontinuation of material from disapproved suppliers.
• To Conduct LIC for the supplier disapprovals.
• To support Site Q representatives for disposition of materials required for production.
• To maintain supplier complaint log with all the relevant details.
• To ensure that all supplier related complaints are resolved in stipulated time period in coordination with suppliers.
• To identify repeat complaints from RM/PM supplier and follow-up with Procurement / ES technical / Supplier Quality Ops for resolution and support.
• To follow up with supplier quality Operation for escalated complaints.
• To provide continuous support to improve business performance by support to Procurement function and Supplier Quality Ops., where required.
• To provide the supplier complaint KPI to SQOps.
• To provide Data collection form to SQA&C as the pre-audit data collation details for supplier audit.
• Approval of SQOPS change control related to supplier change control details relevant to ES site suppliers
• To raise Change controls/Deviation related to revision of Approved Supplier List.
• Preparation / Revision of SOP as per QMS gap assessment.
• Ensure a site of inspection readiness for above mentioned activities.
• To perform the activities assigned by the supervisor as and when required.
Desired Skills & Experience:
- Good knowledge of Microbiological and QC analysis/ Documentation/ Regulatory requirements and Quality Management System.
- Effective verbal and communication skills, collaborative team member & team leader.
- Capable to work independently.
Qualification: Graduate in Science / Pharmacy discipline
Area of Specialization: Quality Assurance / Pharmaceutical Sciences/ Microbiology
Experience: 1 to 5 years’ experience in Corporate Quality Assurance and in Pharmaceuticals formulations, in Supplier Management, , Documentation and SOP management.
- Demonstrated experience in managing w.r.t microbial method transfers and method verification.
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