Join a leading Swiss sterile manufacturing operation as a Sr. Quality Assurance Expert driving GMP excellence, operational partnership, and continuous quality improvement.
Proclinical is seeking a Sr. Quality Assurance Expert to support quality assurance activities within sterile manufacturing operations in CH. This role focuses on ensuring Good Manufacturing Practice compliance, collaborating with operational departments, and driving quality improvements aligned with global and local standards.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Manage and maintain quality assurance activities to ensure GMP compliance.
- Act as the single point of contact for assigned quality-related activities.
- Author, review, and approve SOPs, gap assessments, risk assessments, cleaning documents, and work instructions.
- Coordinate, review, and approve quality records such as deviations, CAPAs, change controls, and validation documentation using Trackwise and KNEAT systems.
- Provide Quality Assurance oversight for manufacturing activities and support SMEs during investigations, including root cause analysis and action plan implementation.
- Participate in quality system improvement projects and lead lean initiatives to enhance efficiency.
- Monitor project progress and communicate updates effectively in local and global meetings.
- Liaise with external partners to establish release strategies for deliverables.
- Define, manage, and report Quality Key Performance Indicators (KPIs).
- Support audits, inspections, and interactions with authorities as needed.
- Onboard new team members and provide guidance aligned with organizational values.
- Deputize for the Team Lead Quality Assurance Operations when required.
Key Skills and Requirements:
- Academic degree (Master or PhD) in Chemistry, Biology, Pharmacy, or equivalent.
- Professional experience in Quality Assurance or Quality Control within pharmaceutical manufacturing.
- Strong problem-solving, decision-making, and planning skills.
- Knowledge of cGMP and regulatory compliance relevant to manufacturing operations.
- Excellent English communication skills; German proficiency is an advantage.
- Ability to prioritize tasks effectively and collaborate with cross-functional teams.
- Familiarity with quality systems and tools such as Trackwise and KNEAT.
If you are having difficulty in applying or if you have any questions, please contact Olivier Worch at o.worch@proclinical.com.
Apply Now:
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Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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