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QA Specialist - 18 Months Training Programme

The Programme

Position Summary:

  • Drive quality culture and promote Good Manufacturing Practice (GMP) compliant behaviors to the site.
  • Ensure site compliance to Pfizer Quality Standards (PQS) and ICH guidelines.
  • Provide oversight to the site GMP operations to ensure products produced in compliance with PQS.
  • Collaborate with cross functional teams to improve quality systems.
  • Understand regulatory expectations and support site inspection readiness. 

What You Will Do

  • Review and approve GMP documentation.
  • Manage control and issuance of GMP controlled documentation.
  • Manage GMP documentation systems e.g. PDOCS.
  • Support the qualification and maintenance of validated state of GMP systems, equipment and processes (including analytical methods).
  • Ensure adherence to quality procedures, regulatory requirements and cGMPs.
  • Improve quality assurance systems, as necessary.
  • Review and approve deviations according to the site procedures. This includes reviewing and approving the investigation reports, ensuring the adequacy of the associated corrective actions and/or preventive actions, performing the impact assessment with the subject matter experts for quality/validation/regulatory impact. Ensure issues are escalated according to the Pfizer Quality Standards (PQS).
  • Conduct internal audits to ensure the internal controls are effective.
  • Maintain inspection readiness and support inspections from regulatory agencies and customers. Actively participate in GMP walk downs to ensure site operation and facility maintained in inspection ready state. 

Organizational Relationships:

The incumbent will interact with all site departments for GMP related operations and activities i.e. Manufacturing Operations Process Teams, Quality Control, Warehouse, Tank Farm, Engineering, New Production Introduction and Technical Services teams.

In the event of quality or regulatory related issues, this position will interact with quality or regulatory representatives from drug product sites or Global Chemistry Manufacturing & Compliance (GCMC) teams. 

Required Skills and Abilities

Job Related Requirements:  

  • Demonstrate ability to act decisively and independently to resolve issues.
  • Strong verbal, written communication and presentation skills.
  • Demonstrated ability to perform in a team.
  • Possess a can-do / pride to succeed attitude.
  • Embrace the use of digital technology to scale and speed up every form of interaction and action. 

Education:

  • Bachelor's Degree in Science/Chemical Engineering or equivalent.
  • Diploma in Pharmaceutical/Chemical engineering or equivalent. 

Experience:

  • For Degree holders - A minimum of 1 year - experience in pharmaceutical industry or related industry.
  • Fresh graduates will be considered.
  • For Diploma holders - A minimum of 3 years' experience in pharmaceutical industry or related industry will be considered. 
Closed 8 months ago
Closed 8 months ago
  • Job type:Graduate Jobs
  • Disciplines:

    Engineering Chemical Processing, Pharmacy and Pharmacology,

    ...
  • Citizenships:

  • Locations:

    Singapore (Singapore)

  • Closing Date:30th Dec 2021, 6:00 pm

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