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Computer Systems Validation Specialist

Expired
  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Systems Engineering
  • Date posted: 18/07/2017
  • Job reference: J370621A

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Computer Systems Validation

Job Summary:

The purpose of this position is to ensure that all site automated systems are introduced, maintained and operating in accordance with cGMP's, site and corporate policies and regulatory requirements with a keen focus on Data Integrity. Assist team(s) in the preparation of validation related documentation, standard operating procedures, reports, system quality reviews, identifying deficiencies, preparing CACI (Corrective Actions and Continuous Improvement) documents, test scripts and change controls with regards to automated systems validation.

Responsibilities:

  • Support, review and approve automated system policies and procedures ensuring compliance with cGMP's, site and corporate policies and regulatory requirements (21 CFR Part 11, Annex)
  • Liaise with local and global team members for validation and compliance activities regarding current and future automated management systems
  • QA authorization sign off on the review of change controls, computer system validation documents, and other ancillary documentation supporting the IT and Automation groups
  • Support regulatory inspections and internal audits with a focus on 21 CFR Part 11; EU GMP Annex 11, GAMP and Data Integrity requirements.
  • Evaluate Change Controls, CAPAs and deviations related to automated systems
  • Assist cross-departmental teams in authoring validation related documentation, standard operating procedures, reports, system quality reviews, identifying deficiencies, preparing CAPA's, test scripts and change controls
  • Ensure the Automated Systems Inventory is up to date at all times.
  • Prioritize, manage, and execute multiple projects utilizing Project Management methodology
  • Ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Perform additional team tasks as agreed to support effective running of the Business
  • Check own work and that of others for accuracy ensuring that all work is documented thoroughly

Minimum Qualifications & Experience:

  • Relevant degree in computer science, computer engineering, life science, or any other pertinent degree
  • At least 3 years relevant experience in pharmaceutical industry - specifically with computer systems validation
  • In-depth knowledge of FDA and European compliance regulations and GAMP guidelines applicable to computer system validation
  • Extensive knowledge of validation deliverables associated with each step of the computer system life cycle
  • Knowledge and proven application of established risk management processes
  • Previous cross-functional project experience

For more information contact James on 016455250 or email james.kelly@experis.ie

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