포스팅 날짜: Mar 25 2025
Purpose
To supervise a team of manufacturing leaders and technicians on assigned shift(s) to ensure the execution of production activities and processes within a specific production area (PB1, PB2 and PB3) to ensure the production of high quality and cost-effective bulk drug substances so as to ensure the realization of production and other relevant operational targets. If assigned to normal day, to support all manufacturing activities including planning, scheduling, audit preparation, committee and support project activities including capital project, NCE, IT, continuous improvement.
Responsibilities
Supervise to ensure smooth and optimum plant performance so as to meet production target within specifications, and in the event where an incident occurs, to lead a team of production leaders / technicians on equipment / process troubleshooting and problem rectification.
Plan and monitor staff performance to ensure an effective performance appraisal for the team. Develop and implement development plan for staff.
Plan, schedule, monitor and co-ordinate with supporting departments to ensure the effective deployment and utilization of operational resources to achieve production and turnaround targets. Perform visual inspection during plant turnaround.
Monitor, enforce and comply with the site and value stream procedures so that housekeeping, cGMP, quality, safety, occupational hygiene and environmental protection requirements are met in order to:
Support / facilitate self-inspections.
1. co-ordinate for plant pre-audit preparation.
2. ensure that plant is safe for release for modification work.
Act as the vital link between shift and day staff to ensure smooth and effective transition of responsibilities as superintendent in-charge for the shift. Support all other site initiatives (energy, PCCE, Living Safety, committee, etc.) as required.
Review, collate or prepare and ensure that documentation related to the production function including M-ERP transactions are complete, up-to-date and relevant to ensure proper control and issuance of manufacturing documents.
Identify, implement business improvement initiatives related to plant, production processes, production facilities, etc. to ensure optimal performance of plant to support the achievement of production targets and cost-efficiency.
Act as Site Main Controller / Site Incident Controller to ensure safe and secure operations on site, and in the event where an emergency occurs, manage and contain the situation within stipulated time framework to minimize disruptions to operations.
Prepare the plant items including cleaning, flushing, inspection, isolation, testing and issuing of Safety Work Permit to ensure execution of all maintenance or modifications work in the plant in a controlled and safe manner. Ensure a proper completion and handover of job at the end of the work.
Support the execution of the waste management to ensure safe and effective waste management by staff.
Maintaining oversight on Data Integrity compliance on shopfloor activities and to identify and implement changes to remove DI traps.
Knowledge, Skills & Experience
At least GCE “O” Level certification.
At least 7-10 years of relevant experience in a pharmaceutical industry, with experience in chemical processing.
Competent knowledge of M-ERP transaction.
Good knowledge of GMP and safety requirements.
Basic knowledge of chemical processes.
Good troubleshooting skills.
Good knowledge of equipment operations.
Knowledge of process control.
Knowledge of the production process.
Basic knowledge of raw materials used in production.
Plant inspection skills.
Basic conflict management skills.
Basic interviewing skills.
Supervisory skills.
Effective organisation skills, which includes housekeeping skills.
Effective communication skills.
Auditing skills.
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