ASSISTANT MANAGER
- Malaysia
- Permanent
- Full-time
1.
To plan day to day shift activities in coordination with the superior to and planning in order to
achieve production requirements.
2. Prepare / review / train SOP and EOPs related to operations.
3.
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.
4. Ensures all team members strictly comply with cGMP procedures.
5. Adherence to safety, health, hygiene and environmental measures.
6. Follow dedicated procedures to enter Drug Product building.
7. Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures.
8. Ensures all team members are properly trained before assigning tasks.
9. Strictly implements line clearance procedure. Escalates any issue immediately to superior.
10.
To carry out and ensure that the packing activities are performed as per Standard Operating
Procedures.
11.
To carry out and ensure that the equipment are operated as per Equipment Operating
Procedures.
12.
Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist,
logbooks and other document related to manufacturing activities.
13. Periodically review the log books to ensure that good documentation practices are followed.
14. Ensure documentation and logbooks are properly maintained in the operation area.
15. Periodically review the SOPs points to ensure that the SOPs reflect current practice.
16.
Periodically review Batch Manufacturing Record (BMR) and Batch Packing Report (BPR) to
ensure that the BMR and BPR reflect current practice.
17. Support qualification and validation of equipment and process.
18.
Supports the Preventive Maintenance and Calibration of Equipment and Instrument to be within
due date in coordination with EM and IA.
19. Instructs and ensures all team members in the proper use of required PPEs.
20. Addresses and corrects with audit observations with respect to manufacturing activities.
Sl.No. Job Responsibilities
21.
Responsible for manpower management by allocating defined responsibilities to the team
members.
22.
Responsible for BM/QA/SOP/025 Good Distribution Practices for Medical Device (GDPMD)
and ISO 13485 compliance in daily activities.
23. To record and maintain daily reports.
b) Additional (If any) -
Sl.No. Job Responsibilities
1. Identifies and generates deviations, change control and other related documents in coordination
with QA.
2. Coordinates with other departments such as QA, QC, Warehouse, EM and IA to achieve day to
day production requirements.
3. Conducts training and coaching of newly hired employees
4. Carry out related tasks as assigned.
5. Contributes in handling the problems related to equipment in co-ordination with EM and IA
6.
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 not limited to:
Proper work attire and personal hygiene.
Cleaning and sanitation of work area and equipment.
Maintenance of product integrity.
7. Raising Maintenance Requisition Form regarding problems and handling the concerns in a
correct and proper manner.Key ResponsibilitiesSl.No. Job Responsibilities
1.
To plan day to day shift activities in coordination with the superior to and planning in order to
achieve production requirements.
2. Prepare / review / train SOP and EOPs related to operations.
3.
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.
4. Ensures all team members strictly comply with cGMP procedures.
5. Adherence to safety, health, hygiene and environmental measures.
6. Follow dedicated procedures to enter Drug Product building.
7. Follow dedicated behaviour and hygiene as required in cleanroom area as per procedures.
8. Ensures all team members are properly trained before assigning tasks.
9. Strictly implements line clearance procedure. Escalates any issue immediately to superior.
10.
To carry out and ensure that the packing activities are performed as per Standard Operating
Procedures.
11.
To carry out and ensure that the equipment are operated as per Equipment Operating
Procedures.
12.
Ensure the correctness and accuracy of the data to all the batch records, status labels, checklist,
logbooks and other document related to manufacturing activities.
13. Periodically review the log books to ensure that good documentation practices are followed.
14. Ensure documentation and logbooks are properly maintained in the operation area.
15. Periodically review the SOPs points to ensure that the SOPs reflect current practice.
16.
Periodically review Batch Manufacturing Record (BMR) and Batch Packing Report (BPR) to
ensure that the BMR and BPR reflect current practice.
17. Support qualification and validation of equipment and process.
18.
Supports the Preventive Maintenance and Calibration of Equipment and Instrument to be within
due date in coordination with EM and IA.
19. Instructs and ensures all team members in the proper use of required PPEs.
20. Addresses and corrects with audit observations with respect to manufacturing activities.
Sl.No. Job Responsibilities
21.
Responsible for manpower management by allocating defined responsibilities to the team
members.
22.
Responsible for BM/QA/SOP/025 Good Distribution Practices for Medical Device (GDPMD)
and ISO 13485 compliance in daily activities.
23. To record and maintain daily reports.
b) Additional (If any) -
Sl.No. Job Responsibilities
1. Identifies and generates deviations, change control and other related documents in coordination
with QA.
2. Coordinates with other departments such as QA, QC, Warehouse, EM and IA to achieve day to
day production requirements.
3. Conducts training and coaching of newly hired employees
4. Carry out related tasks as assigned.
5. Contributes in handling the problems related to equipment in co-ordination with EM and IA
6.
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 not limited to:
Proper work attire and personal hygiene.
Cleaning and sanitation of work area and equipment.
Maintenance of product integrity.
7. Raising Maintenance Requisition Form regarding problems and handling the concerns in a
correct and proper manner.Educational QualificationsRequired Education Qualification: B.Sc
Required Experience: 8 - 12 years