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Epicareer might not working properly because your browser javascript is turned off.

What is JavaScript?

JavaScript is like the magic behind making websites interactive. Basically, it makes Epicareer more enjoyable and engaging.
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Find tutorial for your browser below :
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  4. Click Websites.
  5. On the left, click Content Blockers.
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  2. Click. then Settings.
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  1. Go to Settings.
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  4. Click JavaScript.
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Jobs or company...

C&Q Specialist

  • Full Time, onsite
  • Manpower Business Solutions (M) Sdn Bhd
  • Kuala Lumpur, Malaysia
Salary undisclosed
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Job Description : A C&Q specialist makes sure that all systems, facilities and equipment are installed properly and meet the design requirements put in place for the end-users in a pharmaceutical facility.  Develop and consult risk assessment, system impact assessment, validation plans, protocols, and reports that support the qualification and validation of systems.  Develop and consult to execute Commissioning and validation of Protocols for Bioprocess Equipment’s  Develop and execute Commissioning and validation of Clean Rooms, HVAC system, EMS and BMS systems, Clean utilities and black utilities system.  Consult Protocols and Conduct Tests like HEPA Filter Integrity Testing, Air velocity, Recovery Testing, ACPH, Airflow pattern study, DP Monitoring, non- viable particle counting, Viable Particle Counting, Etc.  Consult and execute Commissioning and validation of Pharma Process Equipment’s for API, Fill/Finish and OSD  Preparation of System Boundaries, SLIA, CLIA, QRA, Facility Risk Assessment.  Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.  Investigate deviations, write investigation reports and create summary reports.  Promote eGMP and regulatory compliance into assigned projects.  Exercise good judgement within generally defined practices and policies in selecting methods and techniques for obtaining solutions.  Should have technical knowledge on utilities.  Should have experience in Erection, Commissioning and Qualification of Utilities.  Should have experience and understand on Pretreatment plant, PW, WFI, & Pure Steam.  Hands on Experience with Biopharma Process Equipment. Job Requirement : - Bachelor in Bio tech/ Chemical Engineering -Experience in Biopharma process equipment -2 years to 5 years and above experienced in validation, quality systems, operations, engineering or any combination thereof. -Experience in multiple GMP validation discipline with advance technical knowledge. -Validate experience using traditional, risk based and hybrid approach. -knowledge of validation lifecycle approach (URS,FRS,FAT/SAT, Commissioning IQ, OQ, & PQ Protocol) guidelines, international regulatory requirements and standards and other in. -Experience working with Documentum or Maximo a plus. -Experience interacting with or creating material for representative of regulatory agencies and executive level staff. -Strong Verbal and written communication skill, excellent organizational and time utilization skills. -Industry experience related to cGMP drug manufacturing, validation and chemical process design.