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Job Description: Scientific Technical Specialist
The successful candidate will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance and drug product supply. The candidate will drive or support compliance-based programs and results which include support and/or leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, SOP management, and site procedures.
Essential Duties and Responsibilities:
- Apply critical decision making, project management skills.
- Provide guidance, consulting, interpretation of GMP and regulatory requirements or standards.
- Build collaborative working relationships and effective communications with all stakeholders in all manufacturing operations, analytical testing, quality systems, regulatory, etc. at all levels.
- Ensure deviations are investigated and resolved (within quality as well as functional areas). Lead investigations using root cause analysis techniques, ensure effective corrective actions and preventive actions.
- Support, review and approve as needed the change management program (Change Control).
- Provide guidance and support on equipment qualification, SDLC, raw material release activities, environmental monitoring, as well as support of utilities functions.
- Perform SOP review and approval within Quality and for functional area procedures.
- Participate in the release or rejection of GMP materials and components either through direct batch release support or involvement with critical program issues.
- Conduct all work meeting high standards for quantity, integrity, quality, and GMP compliance.
Additional Skills and Competencies:
- Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, MES
- Experience in drug product filling and inspection practices
- Fluent in English and German
Required Experience and Skills:
- Experience in pharmaceutical, biotech or other regulated industry
- Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols
- Ability to conduct multiple investigations within established deadlines
- Demonstrated ability to manage multiple projects and initiatives
Preferred Education, Experience and Skills:
- A Master's Degree in Engineering, Sciences or related field and at least 5 years of experience in the pharmaceutical, biotech or another regulated industry
- Experience with formal problem-solving techniques and a hands-on approach to problem solving, such as Root Cause Analysis and/or Lean Six Sigma tools
- cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment
- Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification
Are you interested? We look forward to receiving your application. Please apply online. For more information about this position, please contact your Kelly recruiter Ms. Susanne Junker (+41 76 335 16 58),
You can find other interesting positions on our website: www.kellyservices.ch