Senior Scientist Validation (m/f/d)
Responsibilities
- 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
Profile
- Bachelor Degree in Engineering, Chemistry, Pharmacy or Natural Science
- Experience in pharmaceutical industry with MSc degree 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 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
Benefits
- You will work in an international environment
- Continuous support during the assignment
- A very renowned company
About Hays
With over 15 years of experience in the pharmaceutical and chemical industry as well as in biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated experts who want to develop professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – completely free of charge. Register with us and reap the benefits of interesting job offers that match your skills and experience.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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