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Division
Piramal Critical Care
Piramal Critical Care (PCC), a business unit of Piramal Pharma, is the fourth-largest producer of inhaled anesthetics and a global player in hospital generics. We are motivated by our vision of commitment to delivering critical care solutions for patients and healthcare providers across the globe while achieving sustainable and profitable growth for all the stakeholders.
PCC maintains a wide presence across the US, Europe, and more than 100 countries across the globe. Its rich product portfolio includes Inhalation Anesthetics such as Sevoflurane, Isoflurane and Halothane as well as Intrathecal Baclofen therapy, for spasticity management.
PCC has a strong manufacturing and process development experience with wholly-owned, state-of-the-art manufacturing facilities in the United States and India, inspected periodically by the US FDA and the UK MHRA and other regulators. The strategic locations of our facilities help us supply high-quality products around the world, timely at optimal costs.
For more details, please visit https://www.piramalcriticalcare.com/global/
Job Title
Manager - QC
Job Description
Quality Manager - 15 to 18 yeras
Responsibility: -
- Responsible for maintaining GLP, GMP and Data Integrity in quality control department.
- Review of SOP's and STP's of QC department.
- 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/CMC.
- Release ( Approve/Reject) of Raw material, Packing material ,In process, Intermediate and Finished product.
- Timely release of Raw material, Packing material ,In process, Intermediate and Finished product 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 and stability data generated time to time.
- Ensuring preparation of AMC/CMC and Calibration schedules for the instruments and timely completion of same.
- Ensuring qualification of working standards and procuring the reference standard , impurity standards and other laboratory required items.
- Investigation of OOS/OOT/OOC occurred in the quality control laboratory.
- Responsible for Laboratory Incident investigation.
- Responsible for supporting in market complaint investigations
- Responsible for maintaining and continuous improvement on 21 CFR part 11 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 colleagues.
- Review and approve the analytical method transfer/validation/verification protocol and reports.
- Responsible for review and approval of instrument qualification and its compliance.
- Ensure the Analytical Method validation as well method transfer are conducted with an approved protocol and duly documented and approved.
- Present Quality control activities in the weekly review meeting and monthly review meeting to the Senior management.
- Regularly supporting and providing the data as per the requirement from customer and regulatory.
- Develop and prepare work procedure to minimize OHS risks and Adverse Environmental Impact.
- 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
