Assistant Manager-QAS

7 days ago

Bengaluru India Apotex Inc. Full time

Job Description About Apotex Inc. Apotex is a Canadian-based global health company. We improve everyday access to affordable, innovative medicines and health products for millions of people worldwide, with a broad portfolio of generic, biosimilar, innovative branded pharmaceuticals and consumer health products. Headquartered in Toronto, with regional offices globally, including in the United States, Mexico and India, we are the largest Canadian-based pharmaceutical company and a health partner of choice for the Americas for pharmaceutical licensing and product acquisitions. For more information visit: www.apotex.com . Job Summary The position entitles the incumbent to possess adequate practical and technical knowledge on the Quality control techniques and related instruments. Job Responsibilities - Should have good knowledge on qualification of the computer systems as per the GAMP/ 21 CFR/ EU guidelines. - Should have knowledge and hands on experience in handling of eQMS and SAP. - Should have good knowledge on all QMS activities, quality risk management, change controls, deviations and CAPA system etc. - Should have good knowledge on process validation, cleaning validation, computer system validation, equipment qualification. - To ensure the activities going on as per written & approved SOPs instruction and Parameters. - To ensure that critical deviations, Incidents, Changes and CAPA are timely reported and if required investigation shall be performed case to case basis and resolved the problem in coordination with QA Deputy Manager/Manager and document shall be closed as per the time frame of the respective SOPs. - Review of online documentation in production and initiation of required documents as per the QMS. - Preparation of protocol and report, monitoring of Process validation activity. - Preparation of protocol and report, monitoring of Cleaning Validation activity. - Preparation of Annual Product Quality Review. - Equipment's and area clearance certification for product changeover. - Experience in regulatory inspection like USFDA, TGA MHRA etc Job Requirements - Education: - M.Sc. / M. Pharma - Knowledge, Skills and Abilities: - Preparation of SOPs. - SAP Transactions. - Analytical data review. - Batch record review. - Should have IPQA exposure. - Experience: - 8 years to 10 Years At Apotex, we are committed to fostering a welcoming andaccessible work environment, where all everyone feels valued, respected, and supported to succeed. We offer accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

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