AddressPosted Date: Mar 28 2024
Job 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.
Educational Qualifications :
- M. Pharm/ MSc / B. Pharm
Experience Required :
- 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.
At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
LI-GSK
Why Us?
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 organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
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