MST Parenteral Manufacturing Manager
View: 153
Update day: 21-03-2024
Location: Steinhausen Zug ZG
Category: Executive management Production / Operation
Industry: Medical Equipment Manufacturing Biotechnology Research Pharmaceutical Manufacturing
Position: Mid-Senior level
Job type: Contract
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.
- 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.
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.
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Deadline: 05-05-2024
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