QA Validation Engineer

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QA Validation Engineer

ND Reference : JDKR1712090.01QAV

Position available with No Deviation Pte. Ltd. supporting a project in South Korea

General Description:

  • Review and/or approve Protocol Exception and Change Request
  • Prepare, execute and/or support verification and validation documents
  • Manage equipment validation related documents in accordance with client’s operating procedure.
  • Review and/or approve executed equipment/process validation protocols/reports
  • Prepare, review and/or approve validation summary reports.
  • Initiate and/or support Deviations, Change Control and CAPA
  • Support commissioning and qualification execution for thermal mapping of terminal sterilizer and/or other related systems/equipment.
  • Initiate, investigate and/or resolve any exceptions pertaining cleaning verification/validation execution.

Considerations / Requirements:

  • A degree in Engineering or Science disciplines
  • At least 3-5 years’ relevant experience working specifically in the pharmaceutical industry
  • Demonstration of good team management skills
  • Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
  • Proactive, self-starter and capable of working alone or in a team environment
  • Good knowledge of cGMP, GDP and ICH Q10
  • Knowledge of ASTM 2500E risk-based approaches
  • Aware of relevant guidelines for the above systems
  • To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
  • Be IT literate and familiar with Microsoft office suite of applications
  • Proven track record in following and promoting Safety in all aspects of your role
All applications will be held in the strictest confidence with no information shared externally without prior consent.

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