Position: Mid-Senior level

Job type: Contract

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Job content

Proclinical are recruiting an MST Parenteral Manufacturing Manager for a pharmaceutical organisation. This role is on a contract basis and is located in Steinhausen. The client is focused on finding, developing and distribute novelty treatments that assist patients overcome serious illnesses.

Responsibilities
  • Offer impact evaluations of modification requests in line with the corresponding product owner.
  • Assist with the analysis of technical reports and data corroboration actions.
  • Handle manufacturing or grievance investigations that include possible product influence, which involves root cause analysis, CAPA generation and impact examination.
  • Serve as a subject matter expert in sterile manufacturing procedures, with know-how of international regulatory needs such as FDA corresponding to the planning and control of these procedures.
  • You will assist with the process capability analysis as well as the constant process verification of crucial quality features and restrictions at the CMO.
Skills & Requirements
  • Educated to a degree level in an engineering, science or pertinent subject such as chemical, mechanical, bioprocess engineering, biochemistry, pharmacy, microbiology or similar pharmaceutical science topic.
  • At least 6 years of applicable experience with a BS degree, at least 4 years with a MS degree or 2 years of experience with a PhD.
  • Familiarity with formal risk examinations and investigational apparatuses such as pFMEA, Ishikawa Fish Bone.
  • Know-how of sterile manufacturing machineries and processing practices.
  • Previous aberration investigator, GMP change management and complaint investigations experience.
  • Knowledge of SOPs, cGMPs and GLPs with the experience of operating and handling within a regulatory setting.
  • Fluency in the English language, especially technical writing abilities.
  • Capable of working well and guiding a cross-functional team across various cultures.
  • To determine trends and variability across inter-batch data sets, you will possess statistical analysis skills, which involve statistical software platforms such as Minitab, J M P.
  • Communicational capabilities, both written and verbally in the English language.
If you are having difficulty in applying or if you have any questions, please contact Sasha Botha at +41 61 568 79 88.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#QACompliance

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Deadline: 05-05-2024

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