Job Description:
Quality Assurance (QA) Head for PU Microparticles & FvP / QPOur client, a renowned company in the pharmaceutical industry, is currently seeking a Quality Assurance (QA) Head specializing in PU Microparticles and Drug Release (FvP/QP) for their Basel location. In this role as QA Head for PU Microparticles & FvP/QP, you will play a pivotal role in ensuring product quality and compliance with rigorous cGxP standards in the pharmaceutical industry.
You'll have the opportunity to work in a globally expanding company with excellent prospects for the future. The company also prides itself on high employee retention, contributing to a pleasant working atmosphere.
Primary Responsibilities:
- Ensuring independence in business decisions regarding the release of research and marketed drugs.
- Ensuring compliance with GMP requirements in accordance with Directive 2003/94/EC of the EU Commission dated October 8, 2003, for WSJ-340 PU Microparticles DP3 in Basel, Switzerland.
- Responsible for the technical release of locally manufactured products.
- Monitoring and implementing the quality management system.
- Ensuring quality in terms of QA compliance, QA operations, and QC.
- Responsible for managing GMP audits and inspections, including self-inspections and customer audits.
- Monitoring local KQIs and establishing quality management reviews, including site quality risk management, KPI reporting, and global compliance alerts.
Specific Competencies and Skills:
- University degree with a scientific/technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent).
- Several years of experience (> 5 years) in drug release for human use and several years of experience leading a team.
- Qualified Person (dependent on local requirements).
- Expertise in GxP operations, product release activities.
- Quality assurance; knowledge of GMP; health authorities; supplier relationship management; strategic thinking and planning; quality decision-making.
- Functional breadth; staff leadership; organizational scope; size and complexity; cross-border collaboration; project management.
- Advanced communication skills; motivates colleagues and employees.
- Leadership and change management, goal setting and performance management.
- Budget management, operational excellence, risk management.
- Applied business insights, project excellence, stakeholder engagement, organizational knowledge.
Interested?
If you meet the requirements mentioned above and are interested in taking on this exciting position, we invite you to send your application documents to the following email: m.demir@nonstop-recruitment.com.