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BriefCase

Manager - Corporate Quality Assurance Job in Piramal Enterprises Ltd.

Manager - Corporate Quality Assurance

Piramal Enterprises Ltd. 4+ weeks ago
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Job Summary

Description

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.
Qualification :

Qualifications

12 -15 years on industry experience in GMP environment.Experience in GMP QA with technical expertise.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 about DI requirements and recent trends and expectations of regulatorsExperience Conduct of Site audits .Risk Management and Investigation handling expertiseShould be aware of Regulations of formulation and API. Sterile experience would be preferred.Must have faced regulatory inspections and should have experience in making site audit ready
Experience Required :

Fresher

Vacancy :

2 - 4 Hires

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