Senior CSV Specialist
il y a 3 jours
Job Title: Senior CSV Specialist
Company: Optimus Life Sciences
Job Type: Contract (6 Months)
Location: Remote
About Us: Optimus Life Sciences is a leading company in the Biopharmaceutical sector, dedicated to providing innovative solutions for the pharmaceutical industry.
Job Summary: We are seeking an experienced Senior CSV Specialist to join our team. The ideal candidate will have a deep understanding of computer system validation and a strong background in the pharmaceutical industry.
Responsibilities:
- Lead Computer System Validation (CSV) activities: Develop and implement CSV strategies, ensuring compliance with regulatory requirements and corporate standards.
- Collaborate with cross-functional teams: Work closely with engineering, controls, IT, and other departments to evaluate new applications and determine validation requirements.
- Develop and maintain policies and procedures: Create and update policies, procedures, and local VMPs to ensure efficient operations of the CSV department.
- Provide expert technical guidance: Offer technical expertise to the Validation Manager in making GMP decisions concerning computerized system validation.
- Identify and resolve GMP concerns: Serve as the representative or conduit for the Validation Manager, addressing CSV issues and identifying and resolving GMP concerns.
- Monitor industry regulations and trends: Continuously monitor industry regulations and trends, utilizing this knowledge to enhance clients' policies and procedures for completing various tasks related to computerized system validation.
Requirements:
- Experience working in the pharmaceutical industry: 5-10 years of experience working in CSV functions under GMP requirements.
- Client representative experience: Experience as client representative during vendor FAT/SAT execution.
- Communication and teamwork skills: Ability to work in a team and good communication skills.
- Language skills: Fluent in English, French or Dutch skills would be a plus.
What We Offer: We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.
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