Executive recruitment company Monroe Consulting Group Malaysia's Industrial Division is recruiting on behalf of a leading pharmaceutical company that innovates and revolutionises new solutions for everyday treatment to treat patients across 120 different countries. As the business continues to grow and expand, our respected client is seeking a dynamic, technical, and experienced individual for the job of an Associate Manager for Production Packaging. The opportunity is based in Johor, Malaysia.
The ideal candidate will be responsible to ensure the smooth and ideal production for drug product line (packaging).
Key job responsibilities include:
- To plan day to day shift activities in coordination with the superior to and planning in order to achieve production requirements.
- Prepare / review / train SOP and EOPs related to operations.
- To ensure that all production activities are carried out in compliance with the cGMP requirements by strictly adhering to the standard operating procedures and good documentation practices.
- Ensures all team members strictly comply with cGMP procedures.
- Adherence to safety, health, hygiene and environmental measures.
- Follow dedicated procedures to enter Drug Product building, Cleanroom area of Drug Product building as per procedures.
- Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures.
- Ensures all team members are properly trained before assigning tasks.
- Strictly implements line clearance procedure. Escalates any issue immediately to superior.
- To carry out and ensure that the following activities are performed as per Standard Operating Procedures.
- To carry out and ensure that the equipment is operated as per Equipment Operating Procedures.
- Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist, logbooks, and other document related to manufacturing activities.
- Periodically review the logbooks to ensure that good documentation practices are followed.
- Ensure documentation and logbooks are properly maintained in the operation area.
- Periodically review the SOPs points to ensure that the SOPs reflect current practice.
- Periodically review Batch Manufacturing Record (BMR) and Batch Packing Report (BPR) to ensure that the BMR and BPR reflect current practice.
- Support qualification and validation of equipment and process.
- Supports the Preventive Maintenance and Calibration of Equipment and Instrument to be within due date in coordination with EM and IA.
- Instructs and ensures all team members in the proper use of required PPEs.
- Addresses and corrects with audit observations with respect to manufacturing activities.
- Responsible for manpower management by allocating defined responsibilities to the team members.
- Responsible for BM/QA/SOP/025 Good Distribution Practices for Medical Device (GDPMD) and ISO 13485 compliance in daily activities.
- To record and maintain daily reports.
Additional (if any)
- Identifies and generates deviations, change control and other related documents in coordination with QA.
- Coordinates with other departments such as QA, QC, Warehouse, EM and IA to achieve day to day production requirements.
- Conducts training and coaching of newly hired employees
- Carry out related tasks as assigned.
- Contributes in handling the problems related to equipment in co-ordination with EM and IA
- Ensures all production activities comply with all company's corporate quality and safety standards and local regulatory requirements as percGMP andEHS, which includes but not limited to:
- Proper work attire and personal hygiene.
- Cleaning and sanitation of work area and equipment.
- Maintenance of product integrity.
- Raising Maintenance Requisition Form regarding problems and handling the concerns in a correct and proper manner
Key Job requirements include:
- Bachelor's degree in Biotechnology, Chemical Engineering or equivalent.
- Has a strong understanding within pharmaceutical production.
- Good communication skills in English and Bahasa Malaysia.