Description
The Company:My client is a multinational biopharmaceutical company committed to improving the lives of patients worldwide.Their purpose as a company is to discover and develop therapies that will change the course of human health. With a presence in more than 70 countries - and growing - on their behalf I am looking for talented people to grow their business, advance their science and contribute to their unique culture.
Location:
Neuchâtel area, Switzerland
Competences:
The selected candidate for this position will be responsable for Process Validations, Cleaning Validations, Critical Utility & Equipment Qualifications of Oral Solid Dosage forms. Skilled in risk assessment, intuitively develops and justifies the validation approach based upon risk and scientific rationales. Demonstrated experience in managing a team of people in multiple cross functional projects.
Duties and Responsibilities:
- Write qualification and validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports
- Review & approve validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports for which they are a SME
- Review change control documents to evaluate impact on qualified systems and validated processes
- Lead risk assessments
- Manage validation projects; including managing time, resources and budgets
- Develop and justify the validation approach based on risk and a scientific rational
- Co-ordinate and prioritize qualification and validation execution activities, including external vendors and internal departments
- Maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements
- Maintain qualified systems and validated processes in compliance with Celgene procedures
- Prepare and participate during internal and external audits by answering questions, reviewing qualifications and validations with auditors and providing documentation
- Provide mentoring and leadership to Validation Services team
- Establish and maintain effective relationships with internal team, customers and suppliers
Qualifications:
- Bachelor or Master in Life Sciences
- Approx. 7 year's experience in validation
- Knowledgeable with current international regulatory regulations, cGxP requirements and best practices
- Experience in risk management
- Experience in managing projects is a plus
- Good communication skills in English; French is an advantage
- Team player: ability to interact effectively with teams and customers
- Experience in crossfuncional collaboration with other departments
- Fluent in English,French good to have
If you believe you could be considered as a serious candidate for this position please send me your CV in word format on or for any further questions don't hesitate to contact me at . If for any reason maybe this position is not the right one for you,but you are a professional with experience in Pharmaceutical or Bio-tech industry feel free to give me a call or contact me via email and I would love to start a discussion regarding other work opportunities I might have within my clients in Switzerland.
Looking froward hearing from you!