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Lead Validation Engineer

Navi Mumbai, MH
Job Code:
  • Biotechnology & Science
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Job Details

The C&Q Lead will be responsible for on-site C&Q Activities following ISPE/ASTM methodologies utilizing GDP, GEP & CGMP principles.They will lead a team of Validation/Verification, Commissioning Engineers/ subject matter experts to perform the commissioning/qualification of equipment, utility systems, facilities and automation systems for a number of blue chip pharmaceutical clients.We are searching for a driven individual who has +10 Years industrial experience in a C&Q Lead/ Senior Validation/Engineering position with previous work experience in a GMP Environment & Large Scale Capital Project or Start-Up Projects in the Life Science Industry. Other Skills and AbilitiesDetailed understanding of regulations/guide lines & industry practices for C&Q /verification methodologies (ISPE/ASTM). Excellent written and verbal communication skills.Self-motivated and willing to take ownership and drive projects to completion.Excellent organization skills.Ability to handle multiple tasks accurately and prioritize effectively.Ability to work on own initiative or as part of a team.Demonstrates flexibility, attention to detail, an aptitude for analysis and an ability to apply standard problem solving tools for resolution.Interaction and teaming with cross functional teams (Internal/ External) and ability to lead in areas of conflict resolution.Main DutiesC&Q Project lead main duties outlined belowLiaise with Client as representative.Planning, developing, execution, reporting of C&Q Deliverables. Liaison with the Design Lead (Architect Engineer), Project manager, other stakeholders to enable effective leveraging (where applicable) and timely Right First Time execution and compliance of Commissioning & Qualification deliverables.Provide Leadership in assigning work and providing resolution to a wide range of problems.Management of Contractors, scheduling, resources, budget.Trending of data, issuance of reports in a timely & accurate manner to support Project metrics.Review and Approval of Protocols, Reports and associated Deviations as applicable.Maintain Master plans & Inventory of systems.Generation, review and approval of C&Q strategies as applicable.Interfacing with Global/Local client representatives to ensure compliance.Represents the Validation Methodology and outputs at Compliance Quality / Regulatory Inspections.Conducts training as required.Generation of SOPs/ other documentation as applicable.Maintain change control system for projects.
Degree: M.Com. (Commerce) | M.Pharm. (Pharmacy) | M.Sc. (Science) | MA (Arts) | MBA/ PGDM | MCA/ PGDCA

Additional Degree: BA (Arts) | B.Com. (Commerce) | B.Pharm. (Pharmacy) | B.Plan. (Planning) | B.Sc. (Science) | BBA/ BBM/ BBS | BCA (Computer Application) | Diploma-Other Diploma | B.Ed. (Education) | BHM (Hotel Management)

Experience: 8-13


Formulation | Goods Manufacturing Practices (GMP) | Pharmacy | Quality Assurance/ Control
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