CSV Senior Manager

Proclinical are recruiting for a CSV Senior Manager to join a biotech organisation on a permanent basis located in Iceland.

Responsibilities:

• Handle and monitor the implementation of validation protocols, guaranteeing accomplishment and documentation of validation actions in a timely manner.
• Stay updated on industry regulations, guidelines and best practices linked to CSV and incorporate them into the business's procedure.
• Perform risk assessments as well as offer leadership on risk mitigation methods linked to computerised systems.
• Write validation plans, IQ, OQ, PQ protocols and validation reports for multiple computerised systems.
• Evaluate and sign off on user requirement specifications, functional specifications and design specifications connected to computerised systems.
• Work alongside cross-functional teams to outline validation needs for new equipment, systems and system upgrades.
• Other duties may be assigned.

Key Skills and Requirements:

• Educated to a degree level in a computer science, engineering, life science or similar discipline, though an advanced degree would be more ideal.
• Demonstrable experience within computerised systems validation in a regulated organisation such as pharmaceuticals, biotechnology, medical devices, etc.
• Expertise on regulatory needs such as FDA, EMA, etc., as well as industry standards such as GAMP 5, 21 CFR Part 11, etc. connected to CSV.
• Leadership and project management abilities with the capacity to efficiently guide a team and handle various projects concurrently.
• Communication skills both verbally and in writing.
• Works well with others in cross-functional teams and regulatory agencies.
• Familiarity with validation documentation risk assessments and validation implementation.
• Fluency in the English language.

If you are having difficulty in applying or if you have any questions, please contact Ruhee Saleh at r.saleh@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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