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Urgent! Product Quality Expert Job Opening In Singapore, Singapore – Now Hiring beBeeBiopharmaceutical

Product Quality Expert



Job description

Senior Quality Assurance Specialist

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team.

The ideal candidate will have a strong background in Biologics manufacturing and experience with GMP regulations.

They will be responsible for providing quality oversight of upstream and downstream operations conducted at Contract Manufacturing Organizations (CMOs).

  • Key Responsibilities:
  • Provide quality oversight for Drug Substance and Drug Product (DP) manufacturing activities at CMOs.
  • Ensure manufacturing operations adhere to approved Master Batch Records, Standard Operating Procedures, and regulatory requirements.

  • Review and assess critical in-process parameters, deviations, and any potential impact on product quality.

  • Support timely resolution of quality-related issues and ensure decisions prioritize product quality and compliance.

  • Quality Review & Documentation:
  • Ensure that manufacturing deviations, OOS/OOT results, and non-conformances are properly documented, investigated, and closed in a timely manner.

  • Participate in root cause analysis and ensure corrective and preventive actions are effectively implemented.

  • Review and approve batch-related documentation and quality records as required.

  • Cross-Functional Collaboration:
  • Collaborate with regulatory affairs, CMC, and CMO quality counterparts.

  • Contribute to quality risk assessments and decision-making related to manufacturing operations.

  • Support audits, inspections, and product-related investigations to ensure alignment with corporate and regulatory expectations.

  • Qualifications:
  • Bachelor's or Master's degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or related life sciences discipline.

  • At least 5 years of relevant GMP experience in biopharmaceutical manufacturing.

  • Hands-on knowledge of upstream culture and downstream purification processes.

  • Strong understanding of EU GMP/PIC/S GMP regulations.

  • Ability to interpret technical manufacturing data and identify potential quality risks.

  • Excellent communication skills for effective collaboration with internal and external stakeholders.

A strong candidate will possess a Bachelor's or Master's degree in a related field such as Biotechnology, Biochemistry, Microbiology, or Chemical Engineering.

At least five years of experience in GMP environments, preferably in biopharmaceutical manufacturing, will be necessary.

The ideal candidate will also have hands-on knowledge of upstream culture and downstream purification processes.

A strong understanding of EU GMP/PIC/S GMP regulations is essential.

Additionally, the candidate must be able to interpret technical manufacturing data, identify potential quality risks, and communicate effectively with internal and external stakeholders.


Required Skill Profession

Other General



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    Unlock Your Product Quality Potential: Insight & Career Growth Guide


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