GM

Job Description : GM QUALITY ( IQPA MONTREAL CANADA Open to International candidates with 18+ years experience Manager-Quality Assurance(IPQA) department for one of our Biologics manufacturing Facility located in Jadcherla, Mahabubnagar. if you are interested or known someone who might be a good fit, please share the profile with us at Vijayakiran.ch@hetero.com 15 years of experience in Biopharma Industry (e.g., monoclonal antibodies, recombinant proteins, vaccines, or cell culture-based products). Ø Experience should include Quality Assurance (QA) or a combination of Manufacturing Operations and Quality Assurance, with a minimum of 5 years of experience in the Quality Assurance function. Ø Ensure compliance with cGMP, GDP, and applicable regulatory guidelines Ø Provide real-time quality oversight during manufacturing operations. Ø Verify adherence to approved SOPs, Batch Manufacturing Records (BMRs), and validation protocols. Ø Ensure personnel follow approved procedures and aseptic/GMP practices. ØPerform line clearance, area clearance, equipment clearance, and status verification. Ø Monitor critical process parameters and in-process controls. Ø Verify environmental conditions, equipment status, and cleanliness before manufacturing. Ø Ensure sampling is performed according to approved procedures. Ø Responsible for preparation and review of Annual product review reports and CPV reports. Ø Responsible for conducting weekly inspection for manufacturing area. Ø Responsible for performing in process checks during manufacturing as per the respective SOP’s and protocols. Ø Responsible for review of validation, qualification protocols and reports. Ø Responsible for review of incidents and investigation reports. Ø Authorization for issuance of Master cell bank/ Working cell banks. Ø Responsible for preparation and review of risk assessment document in coordination with concerned department.

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