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PSC Biotech Ltd

Computer Systems Validation Engineer II

PSC Biotech Ltd

  • Cork / Dublin
  • Not disclosed
  • Permanent full-time
  • Updated 12/02/2013
  • Catherine O'Brien
this job is expired
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Description

CSV Validation Engineer

 

Responsibilities:

Prepare, review and approve Validation Plans and User Requirements Specification ,

Prepare and Co-ordinate Impact assessments, Vendor /Supplier assessments , Functional Assessments as part Quality Risk Management process. (such as FMEAs)

Review and approve Function Design Specifications, Configuration Specifications.

Participate, review and approve Factory Acceptance Testing and Site Acceptance Testing (FATs and SATs).

Prepare, review and approve Design Qualification, Installations Qualifications, Operational Qualifications, User Acceptance Testing, Performance Qualifications, Process Validation protocols.

Execute validation protocols (DQ, IQ, OQ, UAT, PQ & PVs).

Prepare, review and approve Summary Reports and System Release Notices.

Perform 21 CFR Part 11 assessments, required for 21 CFR Part 11 regulation.

Prepare, review and approve protocol deviations. Perform system trouble shooting. Implement Corrective and Preventative Actions

Review and approve change controls (project change controls) for the QA & Live Environments.

Ensure all validation documentation is in compliance with Corporate policies, local policies /SOPs and regulatory standards such as Annex 11, Annex 15, 21 CFR Part 11, cGMP, cGAMP, GDP, ICH.

Prepare and review and approve validations, SOPs and work instructions

Provide Validation SOPs/ Work Instruction compliance training to project personnel.

Participate and attend in regulatory Audits.

Collaboration with cross functional teams including; Project Engineers, Project Managers, Quality Representative and Compliance Representative and Operational Representatives

Experience:

Experience working in regulated Pharmaceutical or Medical Device industry

3-5 years experience in a Validation or Quality role.

Degree in Science, Engineering or related area.

Skills and Abilities:

Must possess strong project management and organizational skills.

Self-motivation and drive.

Strong PC skills.

Excellent interpersonal, communication (written & oral) & technical report writing skills.

Must be flexible and able to manage multiple priorities simultaneously.

Ref: Computer Systems Validation Engineer II
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PSC Biotech Ltd

PSC Biotech Ltd

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