Manager, Pd Production

4 days ago

Bandar Baru Enstek, Malaysia Fresenius Medical Care Full time

**Goal of Function**:
Responsible and lead PD Production team. Ensure all manufacturing activities are carried out according to the current Good Manufacturing Practices, ISO, Poison Act and Regulations, and meeting the product specifications. Responsible for the production management, consumables, and cleanroom compliance. Develop high performance team for PD Production.

**Roles & Responsibilities**:
1. Responsible for the smooth day to day operation to achieve all the KPI like OEE, output, yield, safety, quality, etc.

2. Supervise, coach and develop the team, to build an engaged and high performance team with the right level of competency with continuous improvement mindset.

3. Responsible for developing and establishing standard operational policies/ procedures/ guidelines for overall PD production, to ensure compliance with most efficient operation, smooth and safe flow of operations.

3. Ensure PD Production comply with strict adherence to all the ISO 13485 / GMP / pharmaceutical regulatory, Safety, OSHA and DOE requirements, company’s policies, all contracts, laws, legal and regulatory requirement.

4. Ensure the PD production SOP/WI, documents, and checklist are established according to requirement, reviewed, and updated timely and team members are trained accordingly and adhered to it.

5. Ensure all audit findings, non-conformance issues, CAPA, trackwise are handled promptly and close timely.

6. Responsible to analyze the manpower utilization / headcount model, space requirements, work flow, material flow and the design of production layout to be efficient and operates at optimum level.

7. Responsible for the department yearly budgeting and quarterly forecasting activities to ensure cost competitiveness, this includes departmental expense and direct/indirect headcount cost, production overhead like consumables.

8. Manage the departmental cost and develop cost reduction programs. Responsible to ensure products are produce at the highest quality level by complying to all the procedures, work actively with Quality team to drive for quality improvement.

9. Establish a process to ensure all the good practices are properly documented, communicated, trained and executed accordingly and consistently.

**Requirements**:
1. Degree in Pharmacy with minimum 4 years of working experience in manufacturing of Pharmaceutical or Medical Device industry.
2. Must be a Registered Pharmacist at Lembaga Farmasi Malaysia.
4. Proficient in reading, writing and speaking both English and Malay Language.
5. Good in analytical, root cause analysis and problem solving skill.
6. Able to multi task, work professionally and drive to achieve the target.
7. Good interpersonal and communication skills.
8. Good teamwork spirit and able to cooperate with different levels of stakeholders.
9. Good in presentation, time management skills.
10. Energetic and independent.
11. Detail-minded, organized, willing to learn and multi-tasker.
12. Six Sigma Green belt certified is an added advantage.
13. Knowledge in SAP, Minitab, and analytical tool will be an added advantage.
14. Preferably a HRDF Certified Trainer (TTT).
15. Willing to travel upon request.

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