itContracting are seeking applications for a CSV Engineer, this is a permanent position based in Cork.
Key responsibilities for this role include:
- Manage, co-ordinate, develop and execute the validation deliverables for new Information System (IS) projects.
- Support and co-ordinate the qualification and validation processes.
- Ensure that all computer-based systems are operating as intended and meet regulatory requirements.
- Perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) specifically associated with Computer Systems Validations & Data Integrity and as developed and defined in project agreements.
- Support activities include but are not limited to; the preparation of Validation/Qualification
- Plans, Risk Assessments, User Requirement Specification, Traceability Matrix, Testing (IQ,
- OQ/PQ), Data Migration, SOPs and Change controls.
- Responsible for ensuring that computerized systems are in full compliance with regulatory requirements, company policies and procedures; this individual will provide compliance leadership, direction and execution in Computer System Validation for new projects.
- Support the resolution of project deviations/errors and provide quality guidance on GxP
- regulatory requirements (including but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11).
The minimum qualifications for this role are:
- A minimum of a Bachelor's Degree with a minimum of 3 years of related CSV industry experience (Pharma/Biotech).
- Validation experience with ERP, MES, LIMS, and Quality Systems is preferred.
- Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 and EU GMP Annex 11 is required.
- Strong knowledge of computerized system development life cycle approach is required.
- The ability to work and make decisions independently and have the flexibility to adapt to changing priorities is required.
- Strong leadership skills and the ability to work in cross-functional team environments, as well as independently.
- Excellent PC skills with proficiency in automation systems.
- Experience of coordination of Quality documentation and qualification/validation documentation.
- Strong written and verbal communication skills are required.
Candidates must be eligible to work in Ireland or currently hold a Stamp 4 Visa to apply.
For more information please apply here or contact Paul Evans ( +353 1 2187769 or paul dot evans at itContracting dot ie )
Evros / itContracting is an equal opportunity employer who seeks to recruit and appoint the best available person for a job regardless of marital / civil partnership status, sex (including pregnancy), age, religion, belief, race, nationality and ethnic or national origin, colour, sexual orientation or disability. Evros / itContracting apply all relevant Data Protection laws when processing your Personal Data.
If you choose to apply to this opportunity and share your CV or other personal information with Evros / itContracting, these details will be held by us in accordance with our privacy policy used by our recruitment team to contact you regarding this or other relevant opportunities at Evros / itContracting.
Ref: ITC3884
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