Officer/Sr. Officer/Executive/Sr. Executive (Quality Assurance) Details

JOB DESCRIPTION

Position: Officer/Sr. Officer/Executive/Sr. Executive (freshers can also apply)
Experience: Having experience of 2- 8 years in Parental plant.

01. To prepare, review and implement Standard Operating Procedures of Quality Assurance.
02. To ensure day to day QA Controls are at place and make QA empowered for the entire plant.
03. To ensure that process need for Quality management system are established, implemented and maintained.
04. To ensure that a document control procedure is adopted to approve, review and update all changes to documents within the scope of the Quality Management System.
05. Responsible for issuance of Quality Management System related formats and maintain the log accordingly.
06. To take necessary follow up related to deviation, change control, incident, material and product destructions, Internal Audit, re-packing activity and corrective & preventive action with respective department.
07. Responsible to prepare risk assessment documents.
08. To ensure that the performance of the Quality Management System is reviewed at planned intervals to ensure its continuing suitability, adequacy and effectiveness.
09. Responsible to maintain the document as per current Good Manufacturing Practices.
10. Responsible to intervene and call meeting to resolve QMS and GMP related queries.
11. Responsible to provide documents for regulatory affair & handling of regulatory queries.
12. Responsible for co-orientation with internal department personnel as well as external parties.
13. Responsible for audit preparation, execution and compliance.
14. Responsible to handle notification to the management related documents.
15. To investigate & review non-conforming events including customer complaints and internal non-conforming events and decide on CAPA & follow through for implementation.
16. Responsible to prepare, review and implement Master list of Standard Operating Procedures.
17. Review of qualification and validation documents.
18. To review and implement Annual Training Plan of GMP/Technical/SOP training and to coordinate with concern department for execution of ATP and maintain training record for same and to trained departmental staff on their respective job.
19. Responsible for verification & implementation of Batch Numbering system.
20. Responsible for allocation of Equipment identification number and review and follow up for updating of equipment/instrument list.
21. Responsible for update/review approved vendor list, vendor qualification planning and documents.