Requisition ID19800 -Posted -BIOCON SDN BHD -DRUG PRODUCT - PACKAGING -Malaysia
Key Responsibilities
- 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.
- 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 packing activities are performed as per Standard Operating Procedures.
- To carry out and ensure that the equipment are 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 documents related to manufacturing activities.
- Periodically review the log books 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 Job Responsibilities
- 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 coordination with EM and IA.
- Ensures all production activities comply with all Biocon corporate quality and safety standards and local regulatory requirements as per cGMP and EHS, which includes but is 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.
Educational Qualifications
Required Education Qualification: B.Sc
Required Experience: 8 - 12 years
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