Company: Shalina Healthcare Pvt ltd
Location: Navi-Mumbai
Job Purpose:
- To lead the team of quality professional in CQA to Review Investigations, Market complaints, CAPA, Gap assessment, Vendor Management, Technical Trainings, Quality Projects, Site Compliance Support and Documentation (MFR/MPR review) etc.
- To ensure/comply Shalina QMS systems in compliance with internal and regulatory requirements.
No. of reporting: 3 to 4
Key duties and responsibilities:
- Review and approve change controls initiated by plants and send to CQA for approval.
- Review and approve vendor qualification documents and ensure effective implementation of the vendor approval system.
- Monitor and ensure that all plants comply with cGMP, cGLP requirements and good documentation practices.
- Support to manufacturing site for investigation and Regulatory Audit compliance.
- Review and approve of CQA guidelines. Update the CQA guidelines in line with the regulatory requirement.
- Review and approve SOP of Corporate departments.
- Review and approve of change controls, deviations, protocols and reports, qualification documents, stability protocols and MFR/MPR of corporate departments.
- Review of R&D documentation.
- Support plants for the review of regulatory compliance report and customer quality agreements as per requirements.
- Ensure that detailed investigations are in place for out of specifications, market complaints, product recall, and stability failures and that appropriate CAPA is planned and executed as per the defined procedures.
- Ensure that all team members are trained and updated in line with regulatory requirements.
- Effective implementation of training policy.
Communications and working relationships:
- Should have adequate experience of facing various regulatory Inspections like SAHPRA (MCC), PICS, EU, NAFDAC, PPB etc.
- Experience of working in Formulation unit.
- Very good functional knowledge and application.
- Proactive approach to internal and external queries.
- Managing multiple stakeholders.
- Should hold high standards of business ethics.
Qualification, Experience and Skills:
B.Pharma, M.Pharma or MS/M.Sc with 18 to 25 years of experience in QA & CQA (with a 10 to 15 years’ experience in manufacturing plant)
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