Site Commissioning & Qualification Lead
For our client, a global pharmaceutical company near Neuchâtel, we are looking for a Commissioning and Qualification Lead to guide the C&Q activities of a new oral solid dosage (OSD) manufacturing building.
The late stage and launch facility (OSD-LSLF) C&Q Lead has the overall management responsibility of the C&Q Firm who will be responsible for Design Qualification, Factory Acceptance Tests, Site Acceptance Tests, Commissioning, Qualification, Hand Over, and Close Out.
Must have Skills/knowledge include:
Degree in Engineering or Science related discipline performed (i.e. life science, Mechanical, Chemical degree).
Minimum of 10 years of relevant pharmaceutical industry experience (with a focus on OSD pharmaceutical application validation in a GMP environment).
Minimum 10 years ‘experience in managing personnel and/or complex projects, including direct experience in managing different Commissioning/Qualification/Validation contractors and activities for large and complex projects.
Strong problem-solving, verbal and written communication skills.
Ability to work independently and to influence and work across organizational boundaries.
Must have strong interpersonal and communication skills, be a team player and be willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
Excellent command of English and preferably French language.
Project and change management experience. Experience with Product Life Cycle Management.
Experienced in Health Authority inspections (preparation, process, presentations, responses drafting, etc.) with direct interactions including face-to-face interaction and response to audit questions.
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