QMS-Quality Assurance GLOBAL CALCIUM

About GLOBAL CALCIUM

Job Description

Responsibilities Preparation and Review of Quality System Standard Operating Procedures as per compliance with ISO & Regulatory guidelines. Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Change Management, edit forms with impact assessment and implementation effectiveness. Receipt, login, review, co-ordination, follow-ups with respective department and tracking of Deviation Management, Laboratory Incidents with implementation of CAPA. Handling of OOSs, incident and OOTs through detailed investigations to establish suitable CAPA. Coordination on Customer Complaints and Customer Returns investigation and relevant CAPA. Handling of Internal Audits and Compliance as per ICH Q7 guidelines. Preparation and Review of Annual Product Quality Review. Coordination in CAPA. Coordination with Purchase/Marketing to fix the vendor audit and conducting vendor audits, relevant CAPA compliance and implementation. Coordination on Training program of Quality System procedures and other relevant procedures. Preparation and coordination for HALAL and Kosher certifications. Review of Vendor questionnaires and Coordination in vendor qualification. Coordination on Audit related activities and relevant documents. Document Management control. Skills: quality assurance,compliance,change control,deviation management,assessment,