Manager - QC

Responsibility:-

• Responsible for maintaining GLP and GMP in QC department.
• Review of SOP’s and STP’s.
• Allotment of day to day work to team members and work planning.
• Identifying training needs of the staff in the department.
• Ensuring that all Analytical Instruments are in good working condition and timely completion of AMC’s and CMC’s.
• Release (Approve/Reject) of raw materials, packing materials. Analytical release (Approve/Reject) of finished product.
• Timely release of In-process, packing materials, raw material, Intermediates and finished products as per procedure to support smooth production.
• Up keeping the laboratory all time ready for regulatory and customer audits.
• Review and approval of stability protocol & stability data generated time to time.
• Ensuring preparation of AMC & Calibration schedules for the instruments and timely completion of same.
• Ensuring qualification of working standard and procuring the reference standard, impurity standards and other laboratory required items.
• Investigation of OOS/OOC/Deviation/Incident occurred in the laboratory.
• Responsible for Laboratory Incident investigation.
• Responsible for supporting in market complaint investigations.
• Responsible for maintaining and continuous improvement on 21CFR compliance.
• Coordinating with Production, SCM, QA, warehouse for timely dispatches.
• Coordination with the external testing laboratories for analysis.
• Ensuring that all documentation work is completed on time.
• Ensuring a safe environment is maintained in the laboratory.
• Regularly provide the training to the QC Collogues.
• Review and approve the analytical method transfer/validation/verification protocols and reports.
• Responsible for review and approval of instrument qualifications and its compliance.
• Ensure the Analytical Method validations as well method transfers are conducted with an approved protocol and duly documented and approved.
• Regularly supporting and providing the data as per the requirement from customer and regulatory.
• Develop & prepare work procedures to minimize OHS risks and Adverse Environmental Impact.
• Involve the regulatory and customer audits to provide the answers for queries 
• Ensure the data integrity checks are conducted regularly to evaluate the health of the system and implement actions as required.
• Responsible to attending the customer calls internally and externally.  Attend QP meetings.
• Coach and develop the QC team.
• As and when additional responsibilities arise and the same shall be taken based on the requirement.