This role will lead both the QA & QC functions and will be a one Quality lead role for all Insulin Product operations. Therefore the candidate will require experience / knowledge from both of these functional operations. Also essential is extensive sterile operational experience with substantial evidence of hosting EU and/or FDA regulatory compliance audits with success.
Ensure that regulatory submissions, submitted to regulatory authorities accurately reflect site practices and that Regulatory Compliance of the facility practices, as per with registered dossiers
Provide effective leadership for the Quality team as a whole, both at a personal level and through the Quality Leadership Team.
Ensure compliant and effective certification and release of product including European batch release by QPs at respective releasing sites.
Directs adherence of all functions to Quality / GMP standards and procedures across all project stages
Effectively contribute for Health, Safety, Environment, Resources Management, Transversal Relations & Continuous Improvement
Should act as a role model in the area of responsibility, with Persuasion, Overall Vision, Integrity, Commitment, Confidence to speak out, Listen and do.
Proactive in implementing best practices or new technologies when appropriate
Site specific knowledge for Supply Chain Management
Qualifications:M Sc, M Pharma
Eligibility to act as a Qualified Person as per EU Directives or equivalent
Member of appropriate professional body
More than 15 years experience within a Quality function in the Pharmaceutical industry.
Having worked in sterile product manufacturing, dealing with and resolving associated technical and quality challenges
Significant hands on knowledge in hosting EU and / or FDA audit compliance regulatory inspections, within sterile operating unit