Purpose of the Role
Cross-functional coordination to all functional units to maintain quality of trial batches and commercial products by supporting production department in troubleshooting, documentation & formulation.
Responsibilities
To play a key role in documentation, formulation, product troubleshooting, SOP preparation, collaborate in preparing the trial product target with all functional units.
A. Preparation & maintenance of documents:
- 1. Asst. Manager (R&D Department) must prepare documents like SOP for R&D Department, MFR and TPP.
- 2. Must take accountability of Log Book, SOP and documents for every instrument.
- 3. Must take accountability of SOP in R&D department.
- 4. Must prepare monthly plan and report
- 5. Collaborate in preparing R&D annual budget report for forecasted product with all functional units.
- 6. Must prepare report for the materials incompatibility in the formulation, failure of the product and the solution for it.
B. Preparation of Formulation:
- 1. Develop formulation, conduct API-Excipients incompatibility test, take respective trials, develop specific machine run/set points for different formulations, take decisions verify and recommend primary packaging suitability in accordance to the trial formula develop, recommend QC for stability zoning, prepare all in process/release parameters and documents for each formulae, recommend secondary and tertiary packing plans to QA, prepare dossier of passed formulae to forward to QA.
- 2. Responsible for reviewing all batch records and ensuring that the production is executed in accordance with the approved formulation.
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 responsibility about the requirement required before formulating any formulation
- 6. Must take responsibility 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.
- 11. Record and maintain the daily self-activity record and ensure that the same has been done for the entire department.
- 12. Must maintain the labelling of every formulation.
- 13. Must take the accountability for the maintenance of every log book in R&D department.
- 14. Must take the accountability to maintain the calibration record of every instruments in R&D department.
- 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 head and colleague of the Quality Control department. Need to be in dotted reporting to the Department Head.
Professional Competencies
- Master’s/Bachelor’s in Pharmacy.
- Minimum 5 years experience in related field.
- Details Oriented.
- Solid 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.
