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Senior CSV Specialist
Il y a 2 mois
Job Title: Senior CSV Specialist
Job Summary:
Optimus Life Sciences is seeking an experienced Senior CSV Specialist to join our team. As a Senior CSV Specialist, you will be responsible for leading the validation of computerized systems, ensuring compliance with regulatory requirements and corporate standards.
Responsibilities:
- Lead the validation of computerized systems, including process control systems, spreadsheets, and benchtop equipment.
- Develop project scopes, implementation plans, and tracking mechanisms to ensure timely completion of validation activities.
- Collaborate with engineering, controls, IT, and other departments to evaluate new applications and determine validation requirements.
- Implement continuous improvements to policies, procedures, and local VMPs to ensure efficient operations of the CSV department.
- Represent the Validation Manager and address CSV issues to identify and resolve GMP concerns.
Requirements:
- 5-10 years of experience working in CSV functions.
- Experience working within the pharmaceutical industry under GMP requirements.
- Ability to work in a team and good communication skills.
- Fluent in English, French or Dutch skills would be a plus.
