Purpose of the Role
Collaborate with department lead to maintain quality of product, preparation of document, analysis of sample provided.
Responsibilities
Analysis of sample provided by the department lead as per specification and to prepare the documents required for the analysis of the product.
A. Preparation & maintenance of documents:
- 1. Must prepare specification for raw materials, packing materials, intermediate products and finished products
- 2. Must take the responsibility for storage and current status of sample.
- 3. Must be responsible for accurate completion of all analytical report.
- 4. Must take the accountability of the report prepared by the juniors in Quality Control department.
- 5. Must take accountability of log book, SOP and documents for every instrument.
- 6. Must take accountability of SOP required in Quality Control department.
B. Analysis of sample:
- 1. Must analyze the sample planned by the department lead.
- 2. Must take the responsibility for storage and current status of particular sample that is provided by department lead to them.
- 3. Must know how to use every instrument and equipment needed to analyze the sample.
- 4. Must take the responsibility for the analysis of the particular sample planned by the department head.
- 5. Must know how to work as per compendium specially pharmacopoeia.
- 6. Must follow specification and SOP in every step.
- 7. Must prepare solution required for the analysis of the sample.
- 8. Provide solution to any analytical problems that arise in the Quality Control Department.
- 9. Must establish and implement specific analytical procedures for in-house products.
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 chemicals.
- 4. Must take the accountability of working standard, reference standard and other samples.
- 5. Must maintain and know the specific location for every documents in the Quality Control department.
- 6. Must have basic knowledge about first aid and action taken during emergency.
- 7. Must take the accountability for the calibration of every instruments used in Quality Control department
- 8. Must inform the immediate senior if any malfunction is observed.
- 9. Must be updated on Good Laboratory Practices.
- 10. Maintain an excellent order of documents and samples such as analytical test methods, analytical reports, production samples, stability samples etc. by specific filing method approved by the department, which ensures its easy retrieval.
- 11. Must be responsible for adherence to safety rules in Quality Control department.
- 12. Must be updated on cGMP, validation, environmental monitoring and new analytical method.
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 inventory records of all the chemicals, reagents, stock solution, microbiological media, and glassware available.
- 3. Must maintain the record of Reference Standard, Working Standard, Controlled Samples (Finished Products and Raw Materials) and Stability chamber samples.
- 4. Must maintain the labelling of every chemicals and preparations that are in the Quality Control department.
- 5. Must take the accountability for the maintenance of every log book in Quality Control department.
- 6. Must take the accountability to maintain the calibration record of every instruments in Quality Control 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 lead.
Professional Competencies
- Bachelor in Pharmacy.
- 2 year experience in Quality Control department for Bachelor in pharmacy and 3 year experience in Quality Control department for Bachelor in Chemistry.
- Details Oriented.
- Basic skills in Microsoft Office.
- People management skills.
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.
Working Conditions:
Factory Operations & Production Management & Home Office as per human resources requisition, job description & designation.
Best Wishes
Toreva Human Resources & Talent Management Function.
