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CQV Lead/ Engineer

4 - 10 years

0 Lacs

hyderabad telangana

Posted:2 days ago| Platform: Shine logo

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Skills Required

commissioning rmg isolators rabs dryer centrifuges fra urs process validation api osd documentum maximo qualification pharmaceutical equipment comil tablet press coating machine blister packing machine vial filling line pfs line gl reactors nutsche filters lyophilizers cqmp vmp cgmp review sheet scaslia clia dqr sraqra sat protocol commissioning protocol iq protocol oq protocol pq protocol cleaning validation protocol fillfinish gmp validation disciplines validation lifecycle approach international regulatory requirements gdp alcoa practices pharma process equipments drafting equipment operation sops microsoft office products

Work Mode

On-site

Job Type

Full Time

Job Description

As a Commissioning and Qualification Engineer for Pharmaceutical equipment, your role will involve working with a range of equipment including RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators, RABs, GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. You will be responsible for developing various protocols such as CQMP, VMP, FRA, cGMP review sheet, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. In addition, you will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Your role will also involve reviewing, analyzing, and interpreting system performance data, handling deviations/discrepancies, conducting investigations, CAPA, and ensuring cGMP and regulatory compliance. Your qualifications and other requirements for this role include: - BS/MS in Engineering (Chemical, Pharma). - 4-10 years of experience in validation, quality systems, operations, engineering, or a combination thereof. - Experience in multiple GMP validation disciplines with advanced technical knowledge. - Knowledge of Validation Lifecycle approach, international regulatory requirements, and standards. - Experience with Documentum or Maximo is a plus. - Strong verbal and written communication skills, excellent organizational and time utilization skills. - Ability to work independently and within project teams. - Industry experience related to cGMP drug manufacturing, validation, and chemical process design. - Strong computer knowledge including Microsoft Office products. Your role will also involve exercising good judgment in selecting methods and techniques for obtaining solutions, maintaining GDP, ALCOA practices, and drafting equipment operation SOPs.,

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