Manager - Corporate Quality Assurance Job in Piramal Enterprises Ltd.
Manager - Corporate Quality Assurance
Piramal Enterprises Ltd.
4+ weeks ago
- Mumbai, Maharashtra
- Not Disclosed
- Full-time
Job Summary
Ensurethat Quality systems are in sync with current regulations by sharing updatedregulatory guidance to all PEL sites and provide training to sites on newregulations.
Updatingsites about warning letters and ensure compliance against each observationacross PEL sites.Provideguidance to sites on mapping and implementing CAPAs.
Handlingprojectswhich are strategic in nature such as QUEST, 24/7 Audit Readiness at sites, Dataintegrity Compliance etc.
Reviewing sites data on process capability ,OEE,Critical complaints ,deviations etc
Preparingandupdating of Corporate Guidelinesin lines with new regulations
Conductaudits at domestic and international sites.
Conductmonthly reviews with all sites. Coordinate and consolidate data for Managementreviews.
Qualification :
Experiencein GMPQA with technicalexpertise.
Shouldhave worked in Corporate quality and should be well versed with roles andresponsibilities of Corporate Quality Function. Should be well versed withrequirements of management reviews.
Shouldbe able to effectively consolidate and present site data to management usingpowerful presentation skills.
Soundknowledge of GMP regulations and guidelines(USFDA,EU,WHO etc).
Goodcommunication skills (Verbal & written).
Adequateexperience in handling data integrity audits. Aware about DI requirements andrecent trends and expectations of regulators
ExperienceConduct of Site audits.
RiskManagementand Investigation handling expertise
Shouldbe aware of Regulations of formulation and API. Sterile experience would bepreferred.
Musthave facedregulatory inspections and should have experience in making siteaudit ready
Description
Responsiblefor drivingcontinual improvement initiatives at all sites.Supportingsites for being ready for audits and inspections. Face inspections forcorporate related responsibilities.Ensurethat Quality systems are in sync with current regulations by sharing updatedregulatory guidance to all PEL sites and provide training to sites on newregulations.
Updatingsites about warning letters and ensure compliance against each observationacross PEL sites.Provideguidance to sites on mapping and implementing CAPAs.
Handlingprojectswhich are strategic in nature such as QUEST, 24/7 Audit Readiness at sites, Dataintegrity Compliance etc.
Reviewing sites data on process capability ,OEE,Critical complaints ,deviations etc
Preparingandupdating of Corporate Guidelinesin lines with new regulations
Conductaudits at domestic and international sites.
Conductmonthly reviews with all sites. Coordinate and consolidate data for Managementreviews.
Qualification :
Qualifications
QUALIFICATION:
M. Pharm / B. Pharm / Masters in science
EXPERIENCE:
12-15 yearson industry experience in GMP environment.Experiencein GMPQA with technicalexpertise.
Shouldhave worked in Corporate quality and should be well versed with roles andresponsibilities of Corporate Quality Function. Should be well versed withrequirements of management reviews.
Shouldbe able to effectively consolidate and present site data to management usingpowerful presentation skills.
Soundknowledge of GMP regulations and guidelines(USFDA,EU,WHO etc).
Goodcommunication skills (Verbal & written).
Adequateexperience in handling data integrity audits. Aware about DI requirements andrecent trends and expectations of regulators
ExperienceConduct of Site audits.
RiskManagementand Investigation handling expertise
Shouldbe aware of Regulations of formulation and API. Sterile experience would bepreferred.
Musthave facedregulatory inspections and should have experience in making siteaudit ready
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