Executive - QA

1. Evaluation of products (New products and New sites)
2. Identifying, collecting, processing, and analyzing data according to established protocol, procedures standards, as appropriate to specific objectives.
3. Establish and maintain policy for documentation of all products.
4. Implements ongoing quality improvement processes working with interdepartmental teams
5. Maintains product consistency throughout product cycle, to include the design, define and build phases through quality checkpoints and testing.
6. Document Evaluation, Sample analysis.
7. Site Audit and Report preparation
8. Technical Audits and Visits / routine monitoring.
9. Checking of control samples
10. Review of Technical Documents ( BMR, BPR, Specifications, COA), Stability data etc
11. Handling of Market complaints / Regulatory Complaints
12. Investigations and subsequent corrective and preventive action plans on customer complaints/ deviations/ OOS/ OOT.
13. Ensuring compliance with respect to agreed specifications
14. Compliance with respect to Quality Technical Agreement

Critical attributes / qualities

Should have Ability to -

1. map the process at the site
2. capture and close deviations / changes
3. communicate (written and verbal) and reciprocate timely
4. Flair for travel and meet different site teams
5. Analyze and provide accurate feedback to HO