Cadila Pharma

Job description:
Core responsibility related to GLP:
Study Director:
1. Approve the study plan and any amendments to the study plan by dated signature.
2. Make the study plan available to RQA for verifying that it contains all information required for compliance with the GLP Principles.
3. Ensure that the RQA have a copy of the study plan and any amendments in a timely manner and communicate effectively with the RQA as required during the conduct of the study.
4. Ensure that study plans, amendments (if any) and Standard Operating Procedures are available to study personnel during conduct of study.
5. Ensure that the final study plan and report for a multi-site study identify and define the role of any Principal Investigator(s) and test facility including test sites involved in the conduct of the study.
6. Ensure that the procedures specified in the study plan are followed, and document the impact of any deviations from the study plan on the quality and integrity of the study, and take appropriate corrective action if necessary; acknowledge deviations from SOP during the conduct of the study.
7. Ensure that all raw data generated are fully documented and recorded.
8. Ensure that computerized systems used in the study have been validated.
9. Sign and date the final report to indicate acceptance of responsibility for the validity of the data and to indicate the extent to which the study complies with Principles of GLP.
10. Ensure that after completion (including termination) of the study; the study plan, the final report, raw data and supporting materials are archived
11. Standardization/validation of new studies
12. Administrative: Requesting and coordinating resources provided by Management. Personnel, Equipments and Facilities to ensure they are adequate and available as scheduled for the proper conduct of the study.
Head of section-toxicology:
13. Overall in-charge of the functions and cleanliness of the section.
14. Training and orientation of the staff.
15. Day to day work allocation to the staff, workers and administration.
16. Ensure receipt of study allocation to respective SD.
17. Help and coordinate with SD for preparation of study plans, draft reports, final reports, archiving etc., and to help in study conduct,
18. Ensure that SOPs are made available to staff and work assigned is done as per SOPs and study plan.
19. Ensure that facilities and materials required for study conduct are made available to SD
20. Ensure that all the reagents, solutions and chemicals in the laboratory areas are labelled and maintenance of GLP records.
21. Co-operation for procurements of materials/animals.
22. Assure that all staff uses appropriate protective clothing and follow all safety precautions.
23. Maintenance and calibration of instruments, air conditioners, ventilation systems, timers and other utilities in the section/department.
24. Coordinating with RQA during the facility audits and study based inspections and complying with RQA audit observations.
25. Preparation of Form B and obtaining its IAEC approval.
Allied responsibility:
26. Co-ordination with IAEC members and scheduling the IAEC meetings.
27. Updation of documents to CPCSEA web site
28. General material procurement.
29. To help in financial matters of facility.
30. To help in facility maintenance,
31. Communication with finance team, purchase team and suppliers.
32. Communication with sponsor's, if specified in study allotment letter.
Any additional responsibility/activity as and when assigned by management which would not arise any conflict of interest.

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