Operation Quality Lead (Value Stream)
GSK
Full time- 10+ years
- Not Disclosed
- Nashik, India
- Post Date: Apr 02, 2024
- End Date: Jun 02, 2024
- 10+ years
- Not Disclosed
- Nashik, India
- Post Date:Apr 02, 2024
- End Date: Jun 02, 2024
Skills:
- Quality control
- bpharm
- mpharm
Job Description:
Responsibilities
- Shall lead team of :10 OQ personnel ensuring shift-based oversight of GMP/ GDP/ Quality activities at site.
- Contact point for any quality issues in manufacturing/ packing operations at site.
- Ensuring in-process checks, adequate gap analysis, impact & risk assessments as per the QMS requirement.
- Ensuring manufacturing & packing operations as per validated & approved processes and prompt escalation of issues.
- Ensuring all-time Inspection Readiness and GxP & Data Integrity compliance site.
- Ensuring timely QA support in activities like investigations, line clearances etc.
- Review/ approval of MFRs, BMRs, SOPs, Change Controls, Deviations /Incidents/ OOS results investigations, CAPAs etc.
- Ensuring review of batch documentation, test results and all other documentation associated with batch certification.
- Management of Deviations, CAPAs, CAPA effectiveness and their trending.
- Appropriate updating, escalations and discussions in the Site Quality Council.
- Ensuring compliance to all regulatory and QMS requirements.
- Participate actively in OE / Leadership edge activity to ensure better implementation of QMS across the site.
- Ensuring inspection readiness and timely completion of actions in VQMS.
- Time bound compliance to Level-3 and Level-4 audits through CAPA tracking.
- Ensuring Site Quality KPI tracking through Inspection Readiness Dashboard.
- Planning and rational deployment of manpower and resource management for Value Stream OQ operations.
- Ensuring training & development of reportee’s in job competency, knowledge upgrade, personality development etc.
- To liaise with stakeholders like QC laboratory, Engineering, Technical, Warehouse and Production for relevant matters.
Qualification & Experience
- M. Pharm/ MSc / B. Pharm
- At least 15 years of experience
- Experience in Quality Assuarance, IPQA, QMS, Quality Oversight in Prharmaceutical industry.
- Experience in Production, Validation & QMS in Pharmaceutical industry
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Salary
Not Disclosed
-
Role
Executive or Officer
-
Area of Practice
- Quality Assurance/ Quality Control
-
Experience
10+ years
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