This role will serve as the Visual Inspection Senior Manager, responsible for establishing and leading the visual inspection program to ensure product inspection readiness. Key responsibilities include developing comprehensive inspection strategies such as Quality Risk Assessments (QRAs), defect kits, and inspection training and qualification programs across fully automated, semi-automated, and manual inspection processes.
You will build and lead high-performing teams to ensure efficient and compliant execution of inspection activities, while taking on additional responsibilities during the initial site startup in strict adherence to regulatory requirements. The role also involves interfacing with clients and leading critical New Product Introduction (NPI) activities for multiple products, ensuring successful technology transfer, process validation, and support through product approval stages, including mock and pre-approval inspections.
Reporting to the Department Lead of Commercial DP
Location : Tuas Biomedical Park with company transport provided islandwide.
Role & 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
- Bachelor's degree / Master Degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences or related field.
- 8 - 10 years in drug product manufacturing, with experience in visual inspection with 3 years of people management experience
- Direct experience in drug product manufacturing, particularly in building and managing visual inspection process and program.
- Experience in a fast-paced CDMO (Contract Development and Manufacturing Organization) environment is desirable.
- Strong interpersonal skills and ability to interact with clients effectively.
