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Hyde Engineering + Consulting
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CQV Lead/ Engineer (OSD/Injectables Process Equipment Qualification

CQV Lead/ Engineer (OSD/Injectables Process Equipment Qualification

Hyde Engineering + Consulting

4 - 10 years

0 Lacs

hyderabad telangana

Posted:2 days ago| Platform: Shine logo

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Skills Required

commissioning injectables rmg isolators rabs dryer centrifuges fra urs process validation cleaning validation investigation capa cgmp regulatory compliance documentum maximo root cause analysis corrective actions qualification pharmaceutical equipment oral solid dosage fillfinish comil tablet press coating machine blister packing machine vial filling line pfs line gl reactors nutsche filters lyophilizers cqmp vmp cgmp review sheet interdependencies system boundary scaslia clia dqr sraqra sat protocol commissioning protocol iq protocol oq protocol pq protocol handling of deviation gdp alcoa pharma process equipments equipment operation sops validation lifecycle approach fatsat validation lifecycle approach international regulatory requirements interacting with regulat

Work Mode

On-site

Job Type

Full Time

Job Description

You will be responsible for performing commissioning and qualification of Pharmaceutical equipment, specifically systems for Oral Solid Dosage, Injectables, and Fill/Finish. This includes a variety of equipments such as RMG, CoMil, Tablet press, Coating Machine, blister packing machine, Vial Filling Line, PFS Line, Isolators (Negative & Positive), RABs (Open and Closed), GL Reactors, Dryer, Nutsche Filters, Centrifuges, Lyophilizers, etc. Your responsibilities will include developing CQMP, VMP, FRA, cGMP review sheet, interdependencies, System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol, process validation, and cleaning validation protocol. You will execute Commissioning, qualification, and validation activities for Pharma Process Equipments for API, Fill/Finish, and OSD. Additionally, you will review, analyze, and interpret system performance data, handle deviations/discrepancies, conduct investigations, CAPA, and ensure promotion of cGMP and regulatory compliance in assigned projects. Furthermore, you will exercise good judgment in selecting methods and techniques for obtaining solutions, maintain GDP, ALCOA practices, and have hands-on experience with Pharma Process Equipments. Drafting equipment operation SOPs will also be a part of your role. Qualifications & Other Requirements: - 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.,

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CQV Lead/ Engineer (OSD/Injectables Process Equipment Qualification