Play a key role in commercial batch manufacturing along with the maintenance of quality and quantity adhering to the JD provided.
Accountable Area – Assist for commercial batch manufacturing and adherence to BMR/BPR, machine assembling, and operation, IPQC, packaging.
Purpose of the Role
Supervise Jr/Operator and work in maintaining quality of commercial batches and documentation.
Responsibilities
A. Preparation and maintenance of documents:
- 1. Must prepare documents like SOP for Production Department.
- 2. Must prepare and maintain Logbook, SOP of Production department.
B. Preparation of Commercial Batch.
- 1. Responsible for the production of commercial Batches under the guidance of Department Head and with adherence to BMR/BPR.
- 2. Must perform regular IPQC as per the BMR/BPR.
- 3. Must crosscheck the workflow as per BMR/BPR.
- 4. Cross check of the dispensed materials labelling and quantity.
- 5. Must take accountability of the cleanliness of Production department.
- 6. Must adhere and crosscheck the adherence to SOPs.
- 7. Must be responsible on the HR management as per the workload under the guidance of the Department Head.
- 8. Must be responsible for the smooth run of all the Machines and utility.
C. Maintenance of working environment
- 1. Must follow the 5S rule during trial formulation of batches.
- 2. Must maintain the work place discipline.
- 3. Must know the work place for each trials.
- 4. Must have basic knowledge about first aid and action taken during emergency.
- 5. Must take accountability for cleanliness in the working areas.
- 6. Must inform the immediate senior if any malfunction is observed.
- 7. Must be responsible for adherence to safety rules in Production department.
- 8. Must adhere to GMP rules.
- 9. Report to the Assistant Manager – Production about all equipment and stationeries required.
- 10. Report to the Assistant Manager – Production about all the equipment repairs required.
D. Preparation and maintenance of records:
- 1. Must record the daily activity in a record file and also have to take accountability for the daily activity of junior staff members.
- 2. Must maintain the labelling of every formulation.
- 3. Must take the responsibility for the maintenance of every log book in R&D department.
- 4. Must take the responsibility to maintain the calibration record of every instruments in R&D department.
Key working relationships (cross functional relationship)
No Cross functional relationship. Internally this job interacts with the department lead and colleagues of the Production Department. Need to be in reporting to the Department Lead.
Professional Competencies
- Bachelor in Pharmacy.
- 1 to 2 years experience/Fresher may also apply.
- 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.
- Hard working & practices prioritization.
Best Wishes
Toreva Human Resources & Talent Management Function.
