Job Responsibilities:

Support manufacturing readiness activities, including preparation and revision of Master Batch Records (MBRs), change requests and other GMP documentation.
Review and update manufacturing procedures, work instructions and controlled documents to ensure compliance with cGMP requirements.
Conduct operational risk assessments and coordinate pre-campaign training to ensure manufacturing readiness.
Support deviation investigations, including root cause analysis (RCA), impact assessments and implementation of Corrective and Preventive Actions (CAPA).
Coordinate and follow up on deviation records, quality-related tasks, rejected materials and audit findings to ensure timely closure.
Assist in product impact assessments and investigations to support batch review and lot disposition.
Collaborate with Manufacturing, Quality Assurance and other cross-functional teams to resolve operational and quality-related issues.
Ensure all activities and documentation comply with site procedures, regulatory requirements and GMP standards.

Job Requirements:

Min Diploma or Degree in Biotechnology, Biopharmaceuticals, Chemical Engineering, Life Sciences or a related discipline.
Relevant experience in pharmaceutical, biotechnology or biopharmaceutical manufacturing environments.
Familiarity with cGMP requirements and pharmaceutical quality systems.
Experience in GMP documentation, Master Batch Records (MBRs), deviation management and CAPA will be an advantage.
Knowledge of root cause analysis (RCA), risk assessments and change control processes is preferred.

Janeve

wa.me/6588183965

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Email me at [HIDDEN TEXT]

EA Personnel : Janeve Ng Choy Tong

C.E.I: R25159176

Company Registration No: 99C4599

Recruit Express Pte Ltd

6 Months Contract Technical Deviation Investigator I PHARMA HJN