Cadila Healthcare Limited
Zydus Cadila is one of India’s leading healthcare companies and a global healthcare provider with strengths all along the pharmaceutical value chain. The group’s state-of-the-art manufacturing infrastructure is spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim. Ahmedabad has received approvals from several regulatory authorities.
Job Title: Deputy Manager,cqa (audit and Compliance) | Zydus Cadila
No. of Posts: 6
Job Description:
- To follow and conduct corporate quality audits compliance verification at in-house manufacturing location as per SOP and annual plan and six Quality Systems.
- To prepare agenda for audit based on available information and resources.
- Review of QMS activities like Complaints, Investigations, Failures, Deviations, CAPA etc.
- ( Sterile ) Audit of manufacturing activities like Media fill, Aseptic practices, Equipment qualification, Visual inspection, Personnel qualification, APQR etc. ( OSD ) Audit of manufacturing activities like Process validation, APQR, Equipment qualification, Visual inspection etc.
- To prepare Audit report and submit the report to group leader.
- To prepare Trending & Assessment of citation/policies.
- To assist in regulatory or external inspections for site readiness.
- Review the draft response prior to submission to regulatory agencies or SMEs.
- To identify and report specific issue to CAC Head.
- To ensure implementation of monthly reports and participation for arranging departmental meetings.
- Compliance Verification for external audits.
- Extension of regulatory/ external and corporate audit observations to in-house manufacturing locations, monitoring, tracking and verification of compliance status of these observations at extended sites.
Qualifications:
Qualification : M.Sc. (Chemistry)/ M. Pharm
Experience : 6 to 9 Years
Desired Skills and Experience :
- ( Sterile Manufacturing ) Exposure in Manufacturing or Quality Assurance of Sterile Manufacturing sites, Biologics, Vaccines. Exposure in Audit of Sterility assurance.( Oral Solid ) Exposure in Manufacturing or Quality Assurance of Oral Solid, Oral Liquid Dosage sites.
- Experience in organization operating in regulatory market, auditing and compliance in six quality systems. Familiar with interpretation of regulatory guidance e.g. Schedule M, USFDA, ICH, PICs, MHRA, WHO
- Hosting regulatory audits and conducting internal corporate audits at manufacturing facilities (Drug Products and Drug substances)
- Good communication skills, effective inter-personal and cross communication skills.
Functional Role:
- To follow and conduct corporate quality audits compliance verification at in-house manufacturing location as per SOP and annual plan and six Quality Systems.
- To prepare agenda for audit based on available information and resources.
- Review of QMS activities like Complaints, Investigations, Failures, Deviations, CAPA etc.
- ( Sterile ) Audit of manufacturing activities like Media fill, Aseptic practices, Equipment qualification, Visual inspection, Personnel qualification, APQR etc. ( OSD ) Audit of manufacturing activities like Process validation, APQR, Equipment qualification, Visual inspection etc.
- To prepare Audit report and submit the report to group leader.
- To prepare Trending & Assessment of citation/policies.
- To assist in regulatory or external inspections for site readiness.
- Review the draft response prior to submission to regulatory agencies or SMEs.
- To identify and report specific issue to CAC Head.
- To ensure implementation of monthly reports and participation for arranging departmental meetings.
- Compliance Verification for external audits.
- Extension of regulatory/ external and corporate audit observations to in-house manufacturing locations, monitoring, tracking and verification of compliance status of these observations at extended sites.
