Corporate Quality Assurance Manager

The role involves independent management of Vendor Qualification and audits, Liaisoning with FDA / FSSAI regulatory authorities, Contract Manufacturing site audits, Market complaint Investigation, Participation in customer Audits, self-inspection audits and support to site QA and R&D.

Work Exp:

Key Responsibilities:

• To monitor & maintain Vendor Qualification status of Raw Materials and Packaging Materials as per SOP including arranging, reviewing and archiving the entire vendor qualification documents including Vendor Qualification, Technical Agreements, Audit reports and compliance.
• Planning of Vendor Audit Schedules and maintaining Approved Vendor Lists
• Vendor approval and linking of Vendor and Item codes in ERP based on VQ documentation and Production requirement
• Arranging for all vendor related documents as needed by Regulatory Affairs for registration purpose or as per customer requirements
• Co-ordination with Third Party testing Labs in case of any additional testing requirements for regulatory filings or customer requirements
• Market Complaint investigation and closure in coordination with Site QA
• Resolving product queries as raised by the customer teams from time to time
• Inspection and evaluation of all the Third party organizations used for Manufacture, Testing or for any other activity by Fullife. Ensuring CAPA compliance and verification
• Participating in FSSAI / FDA Audits, coordinating with FSSAI / FDA Officers for closure of the observations, attending to any queries as raised by FDA / FSSAI, visiting FA / FSSAI offices as per need
• Assisting and providing technical support to Cross functional teams like Site QA/QC/R&D/Mkt/Purchase/Legal in self inspections, finalization of agreements etc.
• International Drug Project Management.
• Travel to Manufacturing site at Khopoli every week and need basis.

Qualifications:

Key Competencies:

• Have strong technical skills, strong communication skills with all the key stakeholders and external customers.
• Ability to evaluate and troubleshoot.
• Proactive, strong-minded, quick thinker and assertive.
• A mature and professional individual who is self-motivated and enthusiastic.
• Able to communicate with management, peers within the organization and customers.
• Auditing and compliance.
• Good Documentation Practices.
• Project Management.