Position Description

12 months Regulatory Conformance Officer (Pharma MNC | West)
Job Code 22002
Division GMP RECRUITMENT SERVICES (S) PTE LTD (EA Licence:09C3051)
Job Placement Location Singapore
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Responsibilities

  • Manage the regulatory submission process by ensuring timely supply of supporting information and regulatory dossier review to achieve timely approval from regulatory authorities.
  • Manage questions from regulatory authorities concerning a regulatory submission by ensuring timely supply of response and supporting information to achieve timely approval from authorities.
  • Manage the implementation of registered commitments to ensure continuous compliance with inspection requirements.
  • Support site change control, investigations and batch release, improvement initiatives through the provision of regulatory advice and act as an initiator or enabler for change implementation.
  • Support external and internal audits.
  • Act as the QA for the review and subsequent implementation actions for changes to pharmacopoeia requirements.
  • Conduct expert reviews of information, facilities and practices used by the business and external parties to ensure implementation of required regulatory strategies and compliance with standards.

Requirements:

  • Min Degree in Chemistry, Chemical Engineering or other relevant Science / Engineering discipline
  • Good knowledge in current Good Manufacturing Practice and relevant standards/ guidance
  • Experience in manufacturing processes, laboratory operations, operational quality, or Compliance & Validation will be an advantage
  • Possess good audit skills and detail knowledge of regulatory processes

To apply, please visit www.gmprecruit.com and search for Job Reference: 22002
To learn more about this opportunity, please contact Goh Bao Yee at baoyee.goh@gmprecruit.com
We regret that only shortlisted candidates will be notified.

GMP Recruitment Services (S) Pte Ltd | EA Licence: 09C3051 | Goh Bao Yee | Registration No: R1766609     

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