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Informationen zur Anzeige:

Head of Quality Assurance (m/w/d)
Courroux (Schweiz)
Aktualität: 29.07.2021

Anzeigeninhalt:

29.07.2021, Baccinex SA
Courroux (Schweiz)
Head of Quality Assurance (m/w/d)
Assure the overall management of all aspects of Baccinex SA Quality Assurance System to secure overall regulatory compliance to GMP (EU/US) at all times for the entire site Optimize the actual quality system to guarantee complete QA overview Responsible for defining the QA strategy and its implementation Provide leadership and manage a team of about 20 persons Be an escalation and decision point for all matters related to quality Heading of the GMP Quality Assurance Team and management of that Team covering all GMP related activities, such as: o Organization of QM systems for deviations, CAPAs, changes, OOS and complaints according to GMP regulations Hosting external client audits and inspections of health authorities Planning, implementation and follow-up of corrective actions resulting from audits and authority inspections Regular reporting to senior management Securing the compliance according to client requirements together with relevant internal stakeholders (e.g. Head of Production, Head of QC, Responsible Person (QP), group leaders, project managers) Organize and assure in a proactive manner the follow-up of the EU and US regulatory environment trends and evolutions
Degree (Master or higher) in Pharmacy or life sciences Excellent knowledge of GMP (EU/US) and relevant regulations (e.g. PhEur., USP, CFR, PIC/S, ICH) Familiar with the various Quality Assurance Systems including: Risk Management, Continuous lmprovement, Management Awareness, Audit & lnspections, Change Control, Deviation Handling and CAPA. Proven experience of 5-10 years in senior and/or leading position in pharmaceutical Quality Assurance, ideally in sterile finished products Excellent written and verbal knowledge of French and English Very good MS Windows and Office skills Very good organizational skills and assertiveness Self-starting personality and solutions-oriented approaches Demonstrated project management skills with the ability to communicate and collaborate with multiple stakeholders Strong oral and written communication and motivational skills

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