Required skills
- Quality Management
- Quality Assurance
- Root Cause Analysis
- CAPA
- GMP
- Pharmaceutical Industry
- Biotechnology Industry
- Life Sciences
- Process Optimization
- Regulatory Compliance
- Microsoft Office
Languages: German
Job description
Proclinical is seeking a Quality Management Specialist to support quality assurance processes, investigate deviations, and drive continuous improvement initiatives within a GMP-regulated environment.
Project overview
Proclinical is looking for a Quality Management Specialist to support quality assurance processes and ensure compliance with internal standards and regulatory requirements. This role involves investigating deviations, conducting root cause analyses, and driving continuous improvement initiatives. You will work closely with cross-functional teams to maintain high-quality standards and optimize processes.
Responsibilities
- Investigate deviations, conduct root cause analyses, and generate detailed deviation reports.
- Participate in initial assessments and coordinate deviations within the Quality Management System.
- Develop, manage, and track Corrective and Preventive Actions (CAPAs) to successful completion.
- Collaborate with Production, Quality Assurance, Engineering, Supply Chain, and other departments.
- Analyze process data and recommend optimization measures for continuous improvement.
- Ensure compliance with internal quality standards and regulatory requirements.
Requirements
Should you have any questions or difficulties with the application, please contact Olivier Worch at [contact removed].
Proclinical is a specialized recruitment consultancy offering career opportunities in the pharmaceutical, biopharmaceutical, biotechnology, and medical device industries.
Proclinical Staffing is also an equal opportunity employer.
- Background in life sciences (e.g., Pharmacy, Chemistry, Biology) or relevant experience in sterile filling processes.
- Experience in the chemical, pharmaceutical, biotechnology, or food industry, especially in GMP-regulated environments.
- Competence in handling deviations, performing root cause analyses, and creating investigation reports.
- Strong analytical and problem-solving skills with a structured approach.
- Familiarity with Quality Management Systems, CAPA, Change Control, and Risk Management processes is advantageous.
- Independent, detail-oriented, and quality-focused work style.
- Fast learner with enthusiasm for new topics.
- Team-oriented personality with excellent communication skills.
- Proficiency in Microsoft Office applications; experience with electronic Quality Management Systems (e.g., TrackWise, Veeva) is a plus.
Project details
- Start: flexible
- Location: Bern, Switzerland, CH
- Languages: German
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