Role Overview
You will play a critical role in supporting the startup of a state-of‑the‑art aseptic manufacturing facility with multiple production lines. Reporting to the Visual Inspection Team Lead, this position will serve to support the startup of AVI/MVI inspection operations in preparation for product inspection readiness (e.g., execution of visual inspection procedures, support for QRAs, defect kit usage, operator training and qualification activities, etc.) for fully automatic, semi‑automatic, and manual inspection processes.
This role will be responsible for performing and supporting daily inspection activities to ensure efficient and compliant execution of product inspection. Additional responsibilities may be required during the initial site startup, while maintaining strict adherence to regulatory standards. Additionally, this role will support client‑related activities and contribute to the fast‑paced and crucial stage of New Product Introduction (NPI) for multiple new products, ensuring smooth execution of inspection runs, technology transfer support, and participation in process validation and product approval activities (e.g., mock‑up and prior approval inspections).
Note: Shuttles to the site are available at selected MRT stations.
Responsibilities :
- Support the installation and qualification of new manufacturing equipment, and own/oversee key equipment packages.
- Develop and implement visual inspection program and procedures, including SOPs, master batch records, and work instructions.
- Hire, train, and manage visual inspection staffs to support validation activities and batch execution.
- Ensure adherence to quality standards and client requirements for visual inspection using fully automatic, semi-automatic and manual inspection processes.
- Collaborate with Engineering and Maintenance to ensure timely calibration and validation of production equipment.
- Work with Manufacturing Science & Technology (MSAT), Validation, Quality, and QC teams to ensure procedures are developed and personnel are trained for new product introductions.
- Stay informed on global regulatory requirements (FDA, EMA, PIC/S, ICH) for visual inspection and product introduction, and remain up to date on current Good Manufacturing Practices (cGMP).
- Demonstrate mastery of Quality Management System (QMS) production support systems such as Change Control, Deviation, CAPA, and SAP.
- Interface with clients for technology transfer and new product introduction (NPI) projects.
- Be accountable for the specified visual inspection areas and ensure adherence to stringent requirements.
- Be flexible to oversee execution during off-hours, if needed.
- Travel as necessary for project oversight, site visits, and be available for extended periods for overseas training.
- Maintain compliance with training requirements for self and staffs at all times.
Requirement :
- Diploma / Degree in Engineering / Pharmaceutical Sciences, Chemical Engineering, Biological Sciences
- 5 years and above of relevant experience in drug product manufacturing, preferably in visual inspection operations
- At least 3 years of people management experience
- Direct experience in drug product manufacturing, particularly in building and managing visual inspection process (MVI/AVI) and program.
- Experience in a fast‑paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
- Strong iInterpersonal skills and ability to interact with clients effectively.
- Fluent in written and verbal communication in English.
- Direct experience with client and regulatory audits is a plus.
- Ability to perform inspection tasks with normal or corrected‑to‑normal vision, including sufficient visual acuity for detecting defects and accurately distinguishing color