Product Quality Executive

PRESTIGE BIOPHARMA LIMITED; Pasir Panjang; On-site; MYR 50,000 - 80,000; Full time

Job summary

A leading biopharmaceutical company in Negeri Sembilan is looking for a Product Quality Executive. This role involves on-site quality oversight during the manufacturing of Drug Substances and Drug Products, ensuring compliance with GMP and internal quality standards. Candidates should have a degree in Biotechnology or a related field, with 3-5 years of GMP experience in biopharmaceuticals. Strong communication skills and hands-on manufacturing knowledge are essential.

Qualifications

• 3–5 years of relevant GMP experience in biopharmaceutical manufacturing.
• Hands-on knowledge of upstream culture and downstream purification processes.
• Excellent communication skills for effective collaboration.

Responsibilities

• Provide real-time oversight of upstream and downstream activities.
• Ensure timely resolution of quality-related issues during manufacturing.
• Participate in root cause analysis and ensure corrective actions.

Skills

Technical expertise in Biologics manufacturing

Knowledge of GMP

Communication skills

Problem-solving

Education

Bachelor’s or Master’s degree in Biotechnology or related field

Job description

Job Summary: The product quality executive position requires an individual with strong technical expertise in Biologics manufacturing to serve as Person in Plant (PIP) during manufacturing campaigns, providing on-site quality oversight including upstream and downstream processes at Contract Manufacturing Organizations. This role is critical in ensuring that manufacturing activities are conducted in compliance with GMP, internal quality standards, and regulatory requirements.

Responsibilities:

Manufacturing Oversight (Person in Plant)

· Act as on-site quality representative during manufacturing of Drug Substance (DS) and Drug Product (DP)

· Provide real-time oversight of upstream and activities.

· Monitor adherence to approved MBRs, SOPs, and regulatory requirements

· Assess critical in-process parameters, deviations, and potential impact on product quality

· Facilitate timely resolution of quality-related issues during manufacturing.

Quality Review & Documentation

· Ensure manufacturing deviations, OOS/OOT, and non-conformances are properly documented, investigated, and closed in a timely manner

· Participate in root cause analysis (RCA) and ensure corrective and preventive actions (CAPAs) are implemented effectively.

Process & Product Knowledge

· Maintain a strong understanding of process development, scale-up, and GMP manufacturing

· Support tech transfer and process validation (PPQ) activities.

Cross-Functional Collaboration

· Work closely with CMOs, internal QA, regulatory affairs, and analytical teams

· Contribute to quality risk assessments for manufacturing operations.

Qualifications

· Bachelor’s or Master’s degree in Biotechnology, Biochemistry, Microbiology, Chemical Engineering, or related life sciences discipline

· 3–5 years of relevant GMP experience in biopharmaceutical manufacturing

· Hands-on knowledge of upstream culture and downstream purification processes

· Prior experience as Person in Plant or equivalent on-site manufacturing oversight role preferred

· Strong understanding of EU GMP / PIC/S GMP regulations

· Ability to interpret technical manufacturing data and identify potential quality risks

· Excellent communication skills for effective collaboration with internal and external stakeholders

· Willingness to travel and work at CMO sites during manufacturing campaigns