6 Months Contract Technical Operations Specialist, PHARMA #HJN
Description
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 janeve.ng@recruitexpress.com.sg
EA Personnel : Janeve Ng Choy Tong
C.E.I: R25159176
Company Registration No: 99C4599
Recruit Express Pte Ltd