U1- QC- Associate Director

Responsibilities:

1. To ensure to follow Good laboratory practices in Lab.
2. To ensure the availability of required reference standards, working standards, primary standards, Impurity standards and chemicals are available to carry out the testing.
3. Handling and Operating of LIMS software.
4. To ensure all the instruments are qualified and in calibrated state at the time of use, master calibration schedule updating and its compliance along with its service personal coordination for its upkeep in case of breakdowns.
5. Create the instrument method for ICP-MS as per STP (or) Protocol in subjected project folder.
6. Preparation and review of Specification & Test procedures, Standard Operating procedures and Protocol & reports.
7. To ensure the current version of specifications, STPs and SOPs, Operational and calibration SOPs are available to carry out the testing.
8. To ensure that analysts are qualified in required testing parameters before putting them in carrying out the job.
9. To ensure the specifications and test procedures are updated according the pharmacopoeia changes / regulatory requirements.
10. Investigation of Occurrences, OOT, OOS, OOC, Deviations, and customer complaints to propose the corrective and preventive actions, tracking of pending CAPAs related to QC and to ensure the timely closing and implementation.
11. To Review / approve the all raw material and In-house intermediates COA’s and Review the all Active pharmaceutical ingredients (API’s) COA’s.
12. To approve/ rejection of all raw material and In-house intermediates.
13. To review the assigned retest dates to RM / Intermediates and APIs.
14. To ensure the timely evaluation of new / supplement monographs of the different pharmacopeias for the applicable products.
15. Review and approval of CCF, Protocols and Reports (Process validation, Cleaning validations, Method Validations, Method verifications, Calibration documents and Stability study etc.) and Product quality review (PQR’s).
16. Review and approval of ICP-MS Batch analysis, Method development, Method validation & verification of Elemental impurities study (ICP-MS & MDS).
17. To coordinate with internal / external engineers to ensure the adherence of Laboratory equipment’s PM schedule.
18. To coordinate with internal/external service engineer to resolve the issues related to Standalone instrument/HPLC/GC/ICP-MS break downs.
19. Daily planning assigned to subordinates who are related to instrumentation/ In-process/Lab supporting sections.
20. Identifying the resource requirement of the department and raise capex & preparation of URS for new instruments coordinating for its approval and ensuring the required resources are available.