About us:
Perigord is a global organisation and leader in the field of integrated Artwork Management System, Artwork Creation and Production Services to the Life Science industry. With an ever-expanding team of over 500 subject matter experts, we support 15 of the top 20 pharmaceutical companies and over 150 Life Science companies to create, manage and distribute their labelling and packaging assets around the globe.
Patient safety is at the heart of everything we do. We have a passion for innovation, are focused on creative problem solving and have a dedicated product development roadmap. Through all of this, our business has grown exponentially. We are set to expand significantly into the future.
Now partnering with Tech Mahindra and sharing a single ambition, we intend to digitally transform the world of labelling and packaging artwork. We aspire to be the leading provider of Life Science and Commercial Labelling, Artwork Production, Artwork Management and Software Solutions to the world's leading brands.
We now have an exciting opportunity for a Validation Engineer to join our growing organisation.
The Role:
The Validation Engineer will serve as a point of contact for validation requirements and qualifications across departments and regions, directing other team members.
The Role involves interaction with internal management, customer representatives, and communicating clearly and concisely to address customer questions.
Your Responsibilities:
- Oversee the validation process for new system implementations and product releases.
- Generate URS, Validation Plans, Risk Assessments/FMEA’s, FDS, RTMs, Design reviews, validation summary reports, IQ/OQ/PQ validation documentation, Standard Operating Procedures, and executing IQ/OQ/PQ protocols.
- Assess software systems based on GAMP 5 Guidelines.
- Perform Gap analysis against 21 CFR Part 11 and Annex 11 regulatory requirements.
- Ensure that Appropriate Systems are in place to evaluate changes to Validated/Qualified Systems from a Computer Systems Validation perspective to ensure they remain in a validated and qualified state.
- Review and approve all Computer Systems/Software Validation Documentation.
- Adhere to all GMPs, compliance/regulatory mandates and quality requirements.
- Support the company to be audit/inspection ready and participate in audits and as required.
- Proactively take action to consistently improve personal knowledge and capability.
- Perform the related duties as assigned to meet departmental and Company objectives
Preferred Qualifications, Training and Experience:
- Bachelor’s degree in Science / Engineering or a related discipline.
- 2 to 3 years relevant experience
- Experience working in the Pharmaceutical and or Medical Device industry
- Experience working with quality management systems.
- Experience working with multiple stakeholders (technical and non-technical) both on-site and virtually.
- Experience adhering to GMP ( Good Manufacturing Practice)
- Strong communication skills, verbal and written.
Job Type: Full-time
Benefits:
- Bike to work scheme
- Company events
- Employee assistance program
- On-site parking
- Sick pay
- Wellness program
- Work from home
Schedule:
Work authorisation:
Ability to Commute:
- Blanchardstown, Dublin, CO. Dublin D15 (required)
Work Location: Hybrid remote in Blanchardstown, Dublin, CO. Dublin D15
