Formulation And Development (F & D)Chemist/ Officer/Sr. officer

Role & responsibilities

1. To help F&D In-charge in testing of RM/PM/FP/IP sample of F&D trials.

2. To take out stability samples every month for re-analysis.

3. To keep stability sample at required temperature and enter these in stability register

4. To prepare stability calendar with help of senior.

5. To enter RM, PM, FP in individual Register and prepare test slips accordingly.

6. To assign control number / report number to products after entry in Register

7. To test these RM/ PM / FP / IP as per specifications given by party or Pharmacopoeia or develop own specification by testing the product discuss the results with F&D In-charge.

8. To prepare proper test report (COA) and maintain chemists rough not book as per FDA rules.

9. To prepare Production documents, QC documents, Validation documents etc., as per need

10. To carryout chemical/Physico chemical test on products and discuss results with seniors.

11. To keep daily written record of work done

For F & D Procurement

1. Responsible for development of mfg. process & take trial batches in consultation with Seniors

2. To check products periodically. To check stability results and plan for new trials

3. To prepare mfg. instruction BOM and master cards for new products developed

4. To suggest for vendor for RM/PM based on trial and trial results

5. To carryout process validation of trial batches

6. To prepare development protocol & report for new product

7. To prepare different protocols & Report as per need.

8. To create indent for RM/PM, equipments needed for trials

9. To arrange for repairs of equipment or M/c. from Maintenance dept.

10. To keep proper records of all trials for easy tracing out

11. Any other topic related to Development or trial left out

12. Surfing for Technical details, whenever required

13. To test RM/FP/Bulk products and report

14. To participate in Technology transfer activities and documents.

15. To support in all activities related to new Product development, testing and reporting as per need of department.

16. To arrange samples for sending to outside Public lab for testing.

17. To keep written record of work done on daily basis