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Engineer CQV

3 months ago

Bengaluru, India People First Consultants Full time

Job :Engineer CQV

Exeperience:710 years

JobDescription:

  • Wouldlike to help making complex biopharma facilities moresustainable.
  • Drivingthe project with Science and Risk based Validation (SRV)concept.
  • Workvery closely with ourcustomers.
  • Haveknowledge of commissioning of Process & Utility systems andcollaborate with multidiscipline teams to integrate pipingdistribution instrumentationand
  • automationservices facilitate and ensure right commissioning across theproject.
  • Goodtechnical knowledge on Piping codes andstandards.
  • Shouldhave knowledge on terminologies of symbols used inPID.
  • PerformC&Q activities in smaller crossdisciplinaryteams:
  • Alignquality and validation concept with customer’s qualitysystem & validationconcept
  • Definescope of C&Q activities in project and scope of work withinquality work package incl. relevant C&Q activities
  • Ensurechanges to scope are brought to the attention of ProjectManagement.
  • Ensureinterfaces to and coordination with other disciplines andcompliance with codes regulations and relevantProcedures.
  • Ensureright level of commissioning processes so as to have smoothqualificationphases
  • Generatevalidation deliverables like commissioning protocolsetc
  • EnsureC&Q documentation is in compliance with GMP and GEP (incl.ASTME2500).
  • Conductfollowup on QAP planned C&Qactivities

Equcation & Experience:

  • Bachelor’sor master’s degree in a relevant science engineering orpharmaceuticalfield.
  • 710years of experience in performing commissioning and / orqualification activities in an FDA regulatedindustry.
  • Ideallyyou will already have experience in equipment and utilityqualification.
  • Shouldhave knowledge with recent edition of ISPE C&Q and GAMP andregulatory guidelines USFDA EU GMP Annexure 11 & 21 CFR 11and ICHguidelines.
  • Handson experience in C&Q activities of processequipment’s (upstream and downstream and clean utilities)in DS facilityqualification
  • Shouldhave experience in validation deliverables like URS P&IDsFAT SAT generation & executionetc
  • Shouldhave good communication and collaboration skills enablinginteraction with many stakeholders from different functions andcultures.