6 Months Contract Technical Deviation Investigator I PHARMA HJN

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

OR

Email me at [Confidential Information]

EA Personnel : Janeve Ng Choy Tong

C.E.I: R25159176

Company Registration No: 99C4599

Recruit Express Pte Ltd