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Our Purpose of ‘Doing Well and Doing Good’ is deeply embedded in our DNA – it’s not just our success that defines us, but the drive to ensure that our business and our people create a positive impact on society.
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Position: Manager – Corporate Quality Assurance Manager
Location: Kurla, Mumbai, Maharashtra, India
- Responsible for driving continual improvement initiatives at all sites.
- Supporting sites for being ready for audits and inspections. Face inspections for corporate-related responsibilities.
- Ensure that Quality systems are in sync with current regulations by sharing updated regulatory guidance to all PEL sites and provide training to sites on new regulations.
- Updating sites about warning letters and ensure compliance against each observation across PEL sites. Provide guidance to sites on mapping and implementing CAPAs.
- Handling projects which are strategic in nature such as QUEST, 24/7 Audit Readiness at sites, Data integrity Compliance, etc.
- Reviewing sites data on process capability, OEE, Critical complaints, deviations, etc
- Preparing and updating of Corporate Guidelines in lines with new regulations
- Conduct audits at domestic and international sites.
- Conduct monthly reviews with all sites. Coordinate and consolidate data for Management reviews.
Desires Skills & Knowledge
- Should have worked in Corporate quality and should be well versed with roles and responsibilities of Corporate Quality Function. Should be well versed with requirements of management reviews.
- Should be able to effectively consolidate and present site data to management using powerful presentation skills.
- Sound knowledge of GMP regulations and guidelines (USFDA, EU, WHO, etc).
- Good communication skills (Verbal & written).
- Adequate experience in handling data integrity audits. Aware of DI requirements and recent trends and expectations of regulators
- Experience Conduct of Site audits .
- Risk Management and Investigation handling expertise
- Should be aware of Regulations of formulation and API. Sterile experience would be preferred.
Experience: 12 -15 years on industry experience in a GMP environment.
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