Executive / Sr Executive

OneSource CDMO is looking for Executive / Sr Executive for QA Document management

Job Purpose

Documentation and Archival

Primary Responsibility :

Strategic

1. Maintain data integrity in all activities at site and ensure appropriate and adequate traceability.

2. To ensure all time readiness for customer and regulatory audits and inspections. Collaborate all cross functional teams' engagement on a day-to-day basis.

3. To ensure the quality compliance of documentation control activities.

4. Implementing and monitoring all quality assurance to ensure compliance with all applicable global regulatory authorities.

Operational:

1. To ensure the cGMP and GDP compliance in the Documentation control activities.

2. Responsible for the management of electronic Document management system (EDMS)activities.

3. Preparation and implementation of standard operating procedures, protocols, etc., pertaining to quality assurance department, in line with global GMP compliance regulations and industry practices.

4. Responsible for Issuance, handling, retrieval and destruction of documents throughout its lifecycle of the department.

5. Issuance, handling, retrieval and destruction of documents as required in time and logged the same such as, distribution of SOPs, specifications, Standard test procedures and al other GMP documents.

6. Issuance of logbooks/register, formats and all extended formats of the departments by verifying the compliance to the master documents.

7. Periodic review of logbooks and compliance.

8. Periodic destruction of documents beyond defined retention period.

9. Supporting to regulatory department for product filing by providing required documents.

10. Contemporaneous updating of records such as logbooks to record management of documents.

11. Handling and Management of documents as outlined in SOP

12. All the documents scanning and stored in QA department in an orderly manner with the type of document, product / batch no. wise with proper label for identification.

13. The documents required for reference/ review/ audit purpose by documentation handled by proper controlling and maintain log.

14. Support quality related activities to other site of OneSource.

15. Responsible for implementation of enterprise management system and active participation in implementation of IT systems.