For our client, a global pharmaceutical company, we are looking for a Parenteral Manufacturing Manager to support commercial manufacturing of drug product.
The contract will be for 9-12 months based in Zug, Switzerland
Managing manufacturing or complaint investigations that involve potential product impact, including root cause analysis, CAPA generation, and impact assessment
Support of process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO.
Providing Impact assessments of change requests in alignment with the respective product owner
Support review of technical documents and data verification activities
Required competencies and experience
Subject matter expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.
Technical knowledge of sterile manufacturing technology and processing techniques.
Experience as deviation investigator, GMP change management and complaint investigations.
Experience and knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.
Strong technical writing skills (English).
Ability to work within and lead cross-functional technical teams, across multiple cultures.
Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, J M P) to determine trends and variability across inter-batch data sets.
Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.
Strong communication skills, both oral and written (English).
Bachelor's degree in relevant engineering or science discipline (chemical/mechanical /bioprocess engineering. biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is strongly preferred.
Minimum of 6 years of experience as a BS degree, 4 years of experience as a MS degree and 2 years of experience as a PhD is required.
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