Executive - QA (FORM)

Roles & Responsibilities:

1. To ensure the compliance of the regulatory and customer requirements.
2. To update myself and implement with the current regulatory guidelines and legal compliance for making it aware to relevant person.
3. Execution and review of validation/verification protocols and reports for cleaning validation/verification study.
4. To review the assessment and evaluation of new product and new equipment introduction for cleaning validation and verification requirement and establish the worst case product as per SOP and current regulatory guidelines as per available Product matrix.
5. To update cleaning validation documents like equipment matrix, product matrix, scientific rationale, attachment IV, attachment V, Validation master plan, sampling manual and Surface area calculation etc.
6. Reporting and addressing of any discrepancies observed during Cleaning Validation activity to report critical and major observation to QA head.
7. Sampling of cleaning validation samples.
8. To investigate any Deviation, Out of Specification related failure in cleaning Validation.
9. To review and evaluate the change control for facility, equipment, processes, control parameters, utilities, key starting materials, procedures and specifications as per respective SOP.
10. To involve in the activity for the risk assessment, control, communication and review of risks to the quality of the drug product across the product lifecycle, systems, utilities, facility and other associated aspects.
11. To prepare & review of Site Master File.
12. To prepare & review of Validation Master Plan.
13. To support audit handling and compliance.
14. To prepare & review of SOPs of QA department.
15. Review and verification of training related documentation activities.
16. Handling of documentation control activities like issuance, retrieval, archival, storage and destruction.
17. To impart training related to cGMP, GDP, SOPs, but not limited to.
18. To follow the procedure related with Quality, Health, Safety, & Environmental policy.
19. Any additional responsibility assigned by superiors and QA Head on the basis of qualification and experience.
    

Qualification: B. Pharm. / M. Pharm.

Designation: Executive

Location: Dahej, Gujarat

Note: OSD Formulation experience mandatory.

Interested candidates share your updated CV on [email removed]