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Senior Computer Systems Validation Specialist

Eingestellt von Aerotek

Gesuchte Skills: Design, Erp

Projektbeschreibung

Aerotek are searching for a Senior Computer Systems Validation Specialist to join our newly established team, providing customer focused scientific and laboratory services, including multivendor instrument, information technology and validation/compliance services.

You will be joining a rapidly expanding company with multiple opportunities in Cork that are developing every day. We are seeking a strong CSV that has had previous experience working in manufacturing sites or laboratories to help shape the way they deliver and change computer systems in biotechnology and pharmaceuticals.

MAIN RESPONSIBILITIES INCLUDE

- Ensure appropriate regulations, such as 21 CFR Part 11, 210/211, 58, 820 regulations, are addressed in validation.
- Coordinate, assist and document validation activities; preparation/approval of protocols and reports.
- Draft, review and approve local validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation. Examples include SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and design/configuration specifications, IQ/OQ/PQ, requirements traceability Matrix, validation plans, validation summary reports and change controls.
- Perform customized systems based on GAMP5 validation for the intended use and environment of the system.
- Assess the impact of system changes thru change management and change control systems; participate in the planning and implementation of change.
- Develop and maintain Validation SOPs, forms, documentation and files.
- Provide project management and technical oversight for Computer Systems Validation Specialists in the field. Main point of contact for services related to the local CSV team.

IDEAL EXPERIENCE

- validation of computer systems for manufacturing, and/or laboratory equipment
- Must have thorough understanding of FDA regulations and computer validation guidance documents
- Familiarity with the following systems: MES, QAD, ERP, Document Management, and Quality Records Management.
- Familiarity with GAMP5 risk based approach along with V model and other approaches to System Development Life Cycle(SDLC) validation
- Computer knowledge of 21 CFR Part 11 including: electronic records, electronic signatures, audit trail, access security, back up/disaster recovery.

Please contact me directly for a full job description - (see below) Allegis Group Limited and Aston Carter Limited operate Employment Businesses and Agencies and are companies within the Allegis Group Inc. group of companies, the fourth largest staffing company in the world, (collectively referred to as the "Allegis Group"). TEKsystems and Aerotek are divisions of Allegis Group Limited. Applicant data will be treated in accordance with the Allegis Group's Privacy Notice . By submitting personal data to any company or division within the Allegis Group, the applicant is providing explicit consent to the use of such data by the Allegis Group and to the transfer of such data to and from the Allegis Group companies within the UK, Europe and outside the European Economic Area in connection with the fulfilment of the applicant's voluntary requests, and the fulfilment of other job opportunities that match the applicant's profile, and confirms that they may be contacted about such job opportunities.

Projektdetails

  • Einsatzort:

    Cork, Irland

  • Projektbeginn:

    asap

  • Projektdauer:

    12 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

  • Kategorie:

    IT Entwicklung, Medien/Design

  • Skills:

    design, erp

Aerotek