Executive/Sr. Executive - Vadodara
22 hours ago
Job description
Role & responsibilities
Department: Corporate Quality Assurance
Designation: Sr. Executive/ Asst. Manager
Role: Vendor Qualification (Auditor Profile)
Job Responsibilities:
- To have adequate qualification, experience, technical knowledge to conduct vendor site audits as per regulatory norms.
- To conduct vendor site audits and to ensure compliance of vendors for Key Starting Materials, Advance Intermediates, APIs, Excipients, Primary Packaging Material, Secondary Printed Packaging Material, Contract Service Providers, Contract Manufacturing Sites, Consumable Materials.
- Ensure vendors meet cGMP (Current Good Manufacturing Practices) regulations i.e. USFDA/ EU GMP/ ISO / applicable standards
- Monitor Corrective and Preventive Actions (CAPA) following the identification non-conformities during an audit.
- Review, compilation of qualification documents & to execute Vendor, Service provider, Contract Manufacturer, Consumable Materials Qualification/Requalification activity.
- To prepare and review procedure for Vendor qualification, Contract Service Provider, Contract Manufacturing and Consumable Materials in line with regulatory requirements.
- To maintain the Vendor list, Technical Agreements for Raw material, Packing material, Service provider, Contract manufacturers & Consumable Materials.
- Handling of Vendor complaint management system.
- To maintain QM Info record in SAP in line with vendor qualification procedure.
- Proficiency in vendor risk assessment and Quality Management Systems (QMS),
- To have experience in Pharmaceutical industry in regulatory environment in Quality management system.
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