Production Manager (Pharmaceutical Manufacturing)

Responsibilities:

• Responsible for the planning, organizing, and controlling of the production plan and operation.
• Establish and maintain procedures to:
  1. Ensure compliance with CGMP.
  2. Manage inventory and assets such as tools, supplies, and equipment, and replenish them in a timely and efficient manner.
  3. Control waste (product rejection/online rejection).
• Author, lead, or adopt new open-source technologies for the organization.
• Manage internal stakeholder relationships (plant and HQ) through regular daily and monthly meetings, liaising with other departments, and supervising team members.
• Participate in developing and administrating capital and major production budgets (Opex and Capex).
• Involve and approve product costing based on standard manpower utilization and overhead for products.
• Own the development and adoption of upgraded government regulations related to GMP and safety audits and inspections.
• Manage resources within pre-defined budgets and timelines, adapting budgets according to changing company priorities.
• Responsible for report submissions such as KPI, Supply vs. Commit, and Commit vs. Demand.
• Monitor and maintain optimum operational levels of machines/equipment, improving productivity where necessary.
• Develop and adopt continuous improvement projects (OEE, Lean Management, TPM, etc.).
• Ensure the manufacturing process meets all quality standards and health and safety regulations.
• Ensure successful Design, Equipment, Installation, Operational, and Performance qualifications on equipment and facilities.
• Manage day-to-day operations of multidisciplinary projects to ensure performance within agreed timelines and budgets, adhering to required specifications.
• Supervise and monitor the performance of production team members and lead projects.
• Coordinate activities within the manufacturing and quality departments to manage the production schedule, ensuring the highest quality standards and safety compliance.
• Communicate with all relevant inter-company contacts; provide adequate information, consult appropriate persons in case of problems, and contribute to the decision-making process.
• Set up and manage production files in accordance with company SOPs, policies, and CGMP to ensure relevant information is readily available during audits.
• Manage the product plan and provide creative solutions to achieve targets.
• Monitor time and action calendars, communicate upcoming due dates, and follow up on key deliverables.
• Handle dosage forms, prioritizing tablet/capsule (OSD) manufacturing and packing.

Education and Qualification:

• Bachelor’s degree in Engineering, Pharmacy, or a related field.
• Strong experience in pharmaceutical production management, including OSD manufacturing and packing.
• Strong knowledge of CGMP, Lean methodologies, and equipment qualification processes.
• Proven ability to manage budgets, optimize resources, and meet production goals.
• Excellent leadership, communication, and problem-solving skills.
• Familiarity with regulatory requirements and audits in pharmaceutical operations.
• Open to non-Malaysian candidates with relevant qualifications and experience.