Looking for Quality Assurance professionals for a globally leading Pharmaceutical Client, leading all the quality related aspects at the external suppliers/ contract manufacturing sites. Key deliverables are as follows :
Lead supplier qualification process
Lead for Technical Meetings
Assessing quality assurance agreements/ quality risk assessment
Single point of contact for all the quality related activities at external suppliers.
Quality compliance w.r.t GMP environment, regulatory affairs, adherence to quality manual
Quality Auditing, change requests, stability reports
Supplier Relationship Manager
Responsible for Team Management
Ideal Background for the candidate :
10 or more years’ experience in the pharmaceutical industry, with direct experience with APIs.
Experience in QA Operations, production, QC and/or other relevant operational areas, but must include minimally 5 years in QA, and 3 years of management and or project management experience.
Strong understanding of regulatory requirements for commercial products.
Proven track record with FDA, EMEA and other Health Authorities.
Strong understanding of risk assessment and risk management fundamentals/tools
Technical understanding of pharmaceutical / biological processes