QA Specialist (Medical) #HYN

Job Descriptions:

• Maintain and continuously improve the Quality Management System (QMS).

• Serve as the document controller for the Quality Manual, Standard Operating Procedures, Specifications, Work Instructions, Forms, Charts, Records and Quality Reports.

• Ensure compliance with GMP, PIC/s, ICH, ASEAN Guidelines, FDA, and other regulatory requirements.

• Prepare the annual Product Quality Review Report and Management Review Reports.

• Manage and follow up on change controls.

• Conduct process deviation investigations and follow up on CAPA implementation for closure.

• Handle quality issues in manufacturing operations.

• Manage customer complaints, product recalls, returns, and counterfeits cases.

• Review and control artwork and drawings for packaging materials.

• Ensure machine testing, trial runs, qualifications, and validation meet compliance requirements.

• Monitor accelerated and real-time stability programs.

• Ensure that Good Documentation Practices and traceability are in place.

• Undertake any additional tasks as assigned from time to time.
  

  
  Job Requirements:

  ·         Degree in Pharmaceutical Science, Engineering, or a related field.

  ·         At least 2 - 5 years of experience in quality assurance within the pharmaceuticals, manufacturing, or medical devices industries

  ·         Strong knowledge of QMS (e.g. ISO 9001, cGMP) with hands-on experience in documentation control and implementation.

  ·         Proven expertise in QA processes, including investigations, change control, CAPA management, audits, and process validation.
  

  If you are interested in exploring this role or other current openings in the market, kindly email me at [email protected] with your resume.

  We regret to inform that only shortlisted candidates will be notified.

  Ashley Loo Yan Ni | R2095115 | EA License Number: 99C4599

  Recruit Express Pte Ltd Company Reg. No. 199601303W