The CQV Engineer performs activities to support the validation activities of the cGMP manufacturing plant in Dublin, Ireland. This includes supporting validation actions for Packaging and Warehousing facility, and temperature mapping of various units / areas. The role is a contract position as part of the CQV team.
- CQV documentation - drafting, reviewing and approving CQV documentation to Regulatory standards and guidelines.
- Co-ordinate and execute Periodic Review and Re-qualification of systems and facilities.
- To co-ordinate and execute validation activity for new product introduction, or changes to secondary packaging processes.
- Accountable for scheduling, tracking, reporting and achieving validation deadlines.
- Input into the core aspects of Operations, Qualification and Validation SOP's.
- Actively contribute to project teams.
- Data gathering and analysis
- Performing data analysis and determine conclusions reached.
- Make informed decisions / recommendations around conclusions reached from data analysis.
- Reviewing and approval of data analysis and reporting.
- Attends departmental and team meetings focused on CQV activities.
- Serve as a CQV representative for internal technical group discussions.
- Understanding and applying industry specific compliance standards/regulations to all Commissioning/Qualification activities with focus on ASTM E2500, Eudralex and FDA standards.
- Developing an understanding of the importance considering impact on cGMP and compliance on decisions made.
- Conducting and participating in Risk assessments, root cause analysis and investigations.
- Signing off and approving protocols, reports, project change controls and deviations.
- Proactively highlighting any issues around compliance.
- Participates in internal and external audits and inspections where required.
- Commissioning, qualification and validation experience in GMP product manufacturing would be required (minimum of 3 years)
- Technical diploma or Degree in Engineering/Life Sciences or greater preferred.
- Thermal mapping experience using an independent thermal mapping system
- Experience in HPRA/FDA environment advantageous.
- Strong technical writing and communication skills
- Ability to close items to completion.
- Ability to pay high level of detail and QA data to very high standard
- Problem solving skills.
- Must be goal-oriented and able to prioritize and manage risks
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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