GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
Post : Operation Quality Lead (Value Stream)
Job Description
• 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.
Candidate Profile
• M.Pharm/ MSc / B.Pharm
• At least 15 years of experience in O
• Experience in Quality Assuarance, IPQA, QMS, Quality Oversight in Prharmaceutical industry.
• Experience in Production, Validation & QMS in Pharmaceutical industry
• IPQA of Tablets and Creams & ointments, Investigations & RCA, CAPA determination Interpretational capabilities, stakeholder management
• Qualifications & validations.
• Fluency in written and verbal English; Advanced computer operational/usage capabilities.
Additional Information
Experience : 15 years
Qualification : M.Pharm/ MSc / B.Pharm
Location : Maharashtra - Nashik Site
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Quality
Req ID : 392963
End Date : 30th April 2024
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