*URGENT8 API Quality Operations Specialist (Biopharma MNC, 6 months contract) #HRY

Location Tuas, Singapore

Employment Type Contract (6 Months)

Working Hours Monday – Friday 8:00 AM – 5:00 PM

About the Role

We are seeking an experienced API Quality Operations Specialist to support quality oversight within a pharmaceutical manufacturing environment. The successful candidate will ensure compliance with GMP requirements and provide quality oversight across manufacturing, engineering, quality control, technical operations, and supply chain activities. This role is offered on a 6-month project basis.

Key Responsibilities

• Provide quality oversight to manufacturing and production operations to ensure compliance with GMP requirements and internal quality standards.

• Review incoming material inspection packages, batch records, manufacturing logs, and product changeover/line clearance documentation.

• Administer quality documentation, including QA holds and quality logs.

• Perform quality release of incoming materials, in-process materials, and finished product batches.

• Participate in investigations related to deviations, non-conformances, out-of-specification results, and quality events involving manufacturing, warehousing, quality control, and incoming materials.

• Support change management activities by coordinating or providing QA oversight to ensure changes comply with established procedures.

• Conduct routine quality walkthroughs of manufacturing, engineering, warehouse, and laboratory areas to ensure ongoing compliance.

• Support new product introductions, operational excellence initiatives, and continuous improvement projects.

• Collaborate with cross-functional teams to maintain product quality and regulatory compliance.

• Perform other quality-related duties as assigned.

Requirements

• Degree or Diploma in Pharmacy, Chemistry, Pharmaceutical Sciences, Biotechnology, Life Sciences, Engineering, or a related discipline.

• Experience in Quality Operations, Quality Assurance, or GMP quality oversight within the pharmaceutical or API manufacturing industry.

• Good understanding of GMP requirements and pharmaceutical quality systems.

• Experience reviewing batch records, quality documentation, investigations, deviations, CAPA, or change control is advantageous.

• Strong attention to detail, analytical skills, and documentation practices.

• Able to work effectively with cross-functional teams in a manufacturing environment.

• Good communication and problem-solving skills.

  Interested applicants, please email your updated CV to ***email_hidden*** or WA 97527630 for more information.

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

  EA Personnel: Lim Ruo Yi, Rachel (R23116144)

  Company EA license No.: Recruit Express Pte Ltd (99C4599)