Quality Systems Specialist (9 months contract) - MEDICAL MNC

Recruit Express Pte Ltd| Date Posted: 13-Feb-2020
EA Licence No: 99C4599|EA Personal Registration No: R1440070
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Job Nature:
Contract
Position Level:
Experienced
Qualification:
Bachelor's / Honours

Job Description

  • Member of the Quality Systems team in ensuring Quality oversight for validation activities
  • Participate in the development and writing of procedures pertaining to the validation procedures.
  • Partner with the SME, assist the Validation team with gap analysis/risk assessment prior to qualification activities, and where gaps are identified, proposed mitigation plans.
  • Participate in validation discrepancy investigations and assist in the writing and review of the discrepancy report
  • Tracking of all validation discrepancy and its associated CAPA closure
  • Review and approve validation documents not limited to protocols and reports
  • Provide support with any validation queries and issues
  • Provide feedback/recommendation to facilities change controls and intervention to the critical systems/utilities
  • Assess for validation impact for process improvements/studies with SMEs and the manufacturing team
  • Support the compliance, regulatory, audits and training activities as required, and any other responsibilities as assigned by Quality Systems Supervisor
  • Adhere to any applicable EHS, Regulatory and corporate requirements.
  • Build strong partnership with all other departments to ensure open communications and acceptance
  • Commit to a fair and respectful relationship to others and behavior in accordance with Shire’s Code of Conduct.
  • Carry out any other duties as assigned by Quality Systems Supervisor

 

Requirements

  • Min Bachelor's Degree in any science discipline
  • Able to start work immediately or within short notice
  • Good interpersonal skill
  • Prior experience in quality department in bio pharmaceutical companies would be advantageous 

 

For interested candidates, please send your most recent and updated resume to [Click Here to Email Your Resume]
Subject heading: Quality Specialist 

Michelle Lee Ser Min
Recruit Express Pte Ltd
(R1440070)
EA Licence No. 99C4599

 

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