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Piramal Pharma

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4.0

based on 1k Reviews

Video summary

269 Piramal Pharma Jobs

Manager - QC

Piramal Pharmasolutions

4.0

based on 1k Reviews

10-18 years

Bharuch

1 vacancy

Manager - QC

Piramal Pharma

posted 1mon ago

Job Role Insights

Flexible timing

Key skills for the job

SCM QC Packaging Analytical Chemistry STP Continuous Improvement

+ 3 more

Job Description

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.