MSAT Validation Senior Scientist

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Proclinical is currently recruiting for a MSAT Validation Scientist for a Senior position based in Boudry, Switzerland. This is a temporary contract position of 12 months.

Join the team and be part of an innovative company that values inclusion, growth, and impact. This company's dynamic work environment offers brilliant opportunities for advancement and they are seeking talented and driven individuals who share a passion for making a difference within the Life Science industry.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Validation Senior Scientist is the subject matter expert in validation processes in ensuring products/processes meet regulatory requirements and quality standards. The incumbent will support all operational aspects of MS&T department including process monitoring/support, change control and deviation closure. This position regularly works cross functionally with Manufacturing, Quality, Logistics, Facilities, Drug Product Development and Vendors.
• Develop, implement and manage the site process validation, and revalidation strategies to meet cGMP and quality requirements on time and on budget to ensure that programs are compliant with Regulatory Authorities' expectations and related SOPs.
• Collaborate with cross functional teams to define the interfaces to equipment qualification / utilities qualification, system qualification and analytical method validation.
• Establish and maintain the Validation Master Plan for process validation. Ensure that all manufacturing processes are validated, overview on state of validation at site is maintained.
• Participate in transfers and launches, liaise with technical development for new products and align on the product validation approach. Contribute to provide experimental data obtained during the validation activities, which will be used to prepare the related registration documentation.
• Author or reviewer for routine validation protocols and reports, associated change controls and supports the execution at the shop floor.
• Develop the strategy for continued process verification that ensures all critical process parameters and quality attributes are monitored or analysed, and actions are defined and taken in case of trends or deviations. Reviews plans for CPV.
• Lead and drive investigation for validation related matters and implement corrective and preventive actions.
• Contribute to all relevant audit inspection and ensure inspection readiness for the site. Ensure compliance with relevant regulatory requirement, GMP, and other industry standards.
• Initiate, drive and implement continuous improvement initiatives to optimize processes, enhance produce performance and drive operational excellence for better quality, safety and efficiency.

Key Skills and Requirements:

• Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science.
• Proven working experience in pharmaceutical industry with MSc degree or experience with BSc and in GMP validation activities are considered an asset
• Strong problem-solving skills, strong verbal and written communication skills.
• Ability to work independently and to influence and work across organisational 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.

If you are having difficulty in applying or if you have any questions, please contact Saulge Hubert on S.Hubert@Proclinical.com or +41 61 508 7073

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.