Quality Investigation Specialist I PHARMA, 6 months contract HJN

Job Responsibilities

• Lead and manage manufacturing deviation investigations within a GMP-regulated pharmaceutical/biopharmaceutical environment.

• Conduct root cause analysis (RCA) using tools such as 5 Whys and Fishbone Analysis.

• Identify root causes and drive corrective and preventive actions (CAPA) through to closure.

• Work closely with cross-functional teams, including Manufacturing, QA, QC, MSAT and Engineering, to resolve manufacturing issues.

• Assess product quality impact and support batch disposition decisions.

• Prepare investigation reports and ensure timely closure of deviations and CAPAs.

• Support deviation trending and continuous improvement initiatives while ensuring GMP compliance.

Job Requirements

• Min Diploma or Degree in Biotechnology, Biochemistry, Chemical Engineering, Pharmaceutical Sciences, Life Sciences or a related discipline.

• Relevant experience in pharmaceutical or biopharmaceutical manufacturing, preferably within biologics, vaccines, API or drug substance manufacturing.

• Proven experience in managing manufacturing deviation investigations, root cause analysis and CAPA implementation.

• Good understanding of GMP requirements, manufacturing processes and quality management systems.

Janeve

wa.me/6588183965

OR

Email me at [Confidential Information]

EA Personnel : Janeve Ng Choy Tong

C.E.I: R25159176

Company Registration No: 99C4599

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