CSV Senior Manager job in Höfuðborgarsvæði, Ísland

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First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Validation

Location: Iceland

This vacancy has now expired. Please see similar roles below...

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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