Sr. No. Job Responsibilities
1. To ensure quality oversight through the defined management review process and to help in identification and resolution of any Quality, Patient Safety and Compliance related issues of site in coordination with HTS, guiding the site appropriately.
2. To identify and resolve any Quality and Compliance related issue of site in coordination with HTS.
3. To escalate the quality and compliance issues to Management.
4. To review site quality and compliance performance and help the site in ensuring a state of control.
5. To be jointly accountable along with HTS for decisions taken by site related to events leading to market action due to impact on distributed products such as, Confirmed OOS finished products, stability / sterility test failures, critical deviations impacting SISPQ of product, Equipment requalification / calibration failure, Cleaning validation failure, process revalidation failure, Equipment cleaning check failure, Issue observed during equipment preventive maintenance.
6. To be jointly accountable along with HTS for decisions taken by site related to events not leading to market action but leading to significant business impact or risk, such as OOS resulting in multiple batch rejections, OOS/ Deviations with no root cause identified, Regulatory observations, critical observation from internal audit , Equipment requalification / calibration failure, Cleaning validation failure, process revalidation failure, Equipment cleaning check failure, Issue observed during equipment preventive maintenance, overdue equipment requalification, Preventive maintenance overdue, Equipment Calibration overdue, Process revalidation overdue and cleaning validation overdue.
7. To be jointly accountable along with HTS for decisions taken by site related to events not leading to market action or significant business impact but classified as Zydus critical alert as per Quality policy 0101-QP-CEQ-00074, titled, “Notification of Critical Events to Management”
8. To be jointly accountable along with HTS for decisions taken by site related to Market Complaints and Adverse Events, likely to impact distributed products including, market complaints that have significant impact on product quality and patient safety, Critical Adverse Events impacting patient safety and Market complaints of counterfeiting or product tampering.
9. To be jointly accountable along with HTS for decisions taken by site related to repeated product / equipment / facility / process / test issues that lead to market action.
10. To be jointly accountable along with HTS for decisions taken by site related to repeated product / equipment / facility / process / test issues, not leading to market action but leading to significant business impact or risk.
11. To be consultant for sites for Operational activities under QC including: - Planning, testing and release of batches across RM, IP, FG, PM and stability. - Analytical Method verification activities. - GLP activities like column management, chemicals and standards management, glassware etc. - Lab. documentation control e.g. SOP revision, STP revisions and analyst qualification / training. - Lab. instrument related activities like calibration, qualification and preventive maintenance. - Ensuring performance on productivity – on time completion of tests at least possible resources. - Other operational activities of QC.
12. To be consultant for sites for Operational activities under QA including: - IPQA related activities like line clearance, sampling, in-process checks, shop-floor GMP compliance and release of batches. - Document control e.g., BMR issuance and retrieval, SOP master, format issuance. - Control sample management. - Training – GMP related training and other topics as per schedule. - Site audit and compliance including monitoring of site quality and compliance index.
13. To approve job responsibility of all direct reporting quality functions of Zydus Lifescience Ltd. and Subsidiaries.
14. To chair Site Technical Review Meeting (STRM) of direct reporting sites and participate in STRM of sites, chaired by HTS.
15. To participate in Corporate Technical Review Meeting.
16. To participate in Management Technical Review Meeting.
