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