Software Validation Compliance Engineer

Ref. no.: MK/36880/IJP

Tags: Software Compliance Engineer Software Validation Compliance Engineer Software Validation Compliance Engineer Gallway Validation Compliance Engineer Software Engineer

Location(s): Connacht Galway Galway city

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 4 - 5 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Michelle Kilcar

Contact e-mail: michelle@ccprecruit.ie

Job description:
Software Validation Compliance Engineer


The ideal candidate should have a thorough working knowledge of GAMP and Medical device / Pharma regulations, specifically 21CFR Part 11, along with a minimum 4 years experience of working in a software validation role within the above industries.

• Ensures that software validation is carried out in compliance with site/corporate policies and SOPs.
• Ensures that best software validation practices are employed by all departments so that computerized systems which have an impact on product or process quality are developed, validated and documented in a manner which provides assurance that the system conforms to both established GMP and Technical requirements.
• Reviews and approves Master Validation Plans, Validation Protocols, URS, FDS and Software Design Specifications and where applicable Risk Assessments along with associated documentation for equipment and systems.
• Verifies that validation studies once complete have been adequately recorded, documented and carried out, in accordance with the approved Master Validation Plan(s) and Validation Protocols
• Ensures that all deviations to protocols and/or deviations to acceptance criteria are adequately controlled, documented and addressed by the Validation Project Team.
• Provides guidance to staff across various functions on software validation to ensure best practice is maintained. Provides guidance and assistance when required with the preparation of validation protocols, software design specifications and associated documentation for equipment and systems.
• Provides software validation/compliance/part 11 guidance in accordance with policies and SOPs.
• Participates in Validation project teams and assists in determining project schedules. Works with teams and other departments across the plant to ensure project adherence.
• Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
  
  Skills, Experience and Qualifications:

• Science or Engineering Degree or equivalent.
• Experience in software and computer systems validation and regulations.
• A thorough working knowledge of GAMP and 21CFR Part 11.
• Minimum 4 years experience of working in a software validation role within the pharmaceutical/medical device or healthcare industry.