To play a key role in documentation, commercial batch production, product troubleshooting, SOP preparation, collaborate with all functional units for commercial batch production
Purpose of the Role
Cross-functional coordination to all functional units to maintain quality and quantity of commercial products.
Responsibilities
A. Preparation and maintenance of documents:
- 1. Asst. Manager (Production Department) must prepare documents like SOP and Logbook
- 2. Must take accountability of Log Book, SOP and documents for every instrument
- 3. Must take accountability of SOP in Production department.
- 4. Must prepare monthly plan and report.
- 5. Collaborate in preparing Production RM/PM requirement for forecasted product with all functional units.
- 6. Must prepare report for the materials incompatibility in the formulation if noticed during batch production.
B. Preparation of commercial batch.
- 1. Must have knowledge about the current Inventory of RM/PM.
- 2. HR management for Batch production
- 3. Must cross check the dispensed RM/PM
- 4. Must fill or crosscheck IPQC data in BMR/BPR during Commercial Batch production.
- 5. Responsible for reviewing all batch records and ensuring that the production is executed in accordance with the approved BMR/BPR.
- 6. Assist QA and QC personnel for the sampling of commercial Batch in process and after completion.
C. Maintenance of working environment.
- 1. Must follow the 5S rule during analysis of sample provided.
- 2. Must maintain the work place discipline.
- 3. Must know the work place for each formulation.
- 4. Must have basic knowledge about first aid and action taken during emergency.
- 5. Must take accountability about the requirement required before formulating any formulation.
- 6. Must take the accountability for the calibration, validation and utilization of every instruments used in R&D department.
- 7. Must inform the immediate senior if any malfunction is observed.
- 8. Must assist in conducting GMP inspections and ensure the strict adherence to GMP rules.
- 9. Maintain an excellent order in filing of analytical test methods, analytical reports, handing of samples and in storage retention samples.
- 10. Must be responsible for adherence to safety rules in R&D department.
D. Preparation and maintenance of records:
- 1. Record and maintain the daily self-activity record and ensure that the same has been done for the entire department.
- 2. Must maintain the labelling of every Batch.
- 3. Must take the accountability for the maintenance of every log book in Production department.
- 4. Must take the accountability to maintain the calibration record of every instruments in Production department.
Key working relationships (cross functional relationship)
Cross functional relationship – this job interacts with other department leads and colleagues of production department. Need to be reporting to line manager (functional lead – FO&PM) and dotted and procedural reporting to Quality Assurance lead.
Professional Competencies
- Bachelor in Pharmacy
- Minimum five years in related field.
- Details Oriented.
- Sold computer skills on Microsoft Office.
- People management skill.
Behavioral Competencies
- Integrity (Instils trust).
- Authentic – communication, behavior & actions Customer focus.
- Manage the professional & procedural ambiguity Plans & alignment with actionable.
- Courageous and soundly confident.
- Flexibility & adaptability.
- Collaborative & building networks.
- Drives business results. Strategic & analytical mindset.
- Hard working & practices prioritization.
Best Wishes
Toreva Human Resources & Talent Management Function.
