Swiss based pharmaceutical company (Ticino) – Alpex Pharma SA – is looking for Head of QA to be part of the team with wide spectrum of activities related to molecules products portfolio and originating from routine internal manufacturing or contract manufacturing, as well as transfer projects from development to commercial phase.
Key responsibilities:
Your responsibilities include, but are not limited to:
- Organization, Review and Approval of all GMP documentation i.e. Protocols, Reports, SOPs, Annual product review, Manuals etc. for Pharma & Nutritional Activities.
- Evaluation of finished product analytical dossier for GMP compliance by signing the certificate of analysis. Evaluation of finished product analytical dossier related to stability analysis by signing the summary page, evaluation of analytical validation dossier by signing the related report.
- Assessment of contract laboratories, vendor Assessment. Carry out quality audits to ensure the quality system of vendors. Coordination and support to external auditors and inspections, carry out self-inspections which regularly appraises the effectiveness and applicability of the QA system.
- Batch release as alternative QP
- Coordination of R&D activities for GMP & Regulatory Compliance
Minimum Requirements:
- Bachelor’s degree in scientific discipline, biopharmaceutical or biomedical science, chemistry, pharmacy or equivalent
- At least 5 years of work experience in similar position or existing senior position in QC/ QA / QP in pharmaceutical industry
- Knowledge of GMP/FDA
- Knowledge of IT Applications & tools
- Fluent English and Italian is a must
- Investigative and analytical critical thinking skills
- Strong decision-making skills
- Continuous interactions is required (both internally and externally with customers)
For further information you could contact Veronica Macokina (+41 91 935 51 10, vmacokina@alpex.com)
Send application and CV to vmacokina@alpex.com