QA/Validation Specialist (Contract Role)
Industry : Healthcare
- Responsible for reviewing and approving qualification and validation activities in a cGMP environment for key site processes, equipment and utilities and on-going process validation, in line with current regulatory requirements, corporate policies and site procedures (as per Validation Master Plans), including the generation/review of validation documentation (schedules/Risk Assessments/Protocols /Reports/Annual Reports).
- Presenting executed qualifications during internal and external audits.
- Ensuring that a continuous state of validation is maintained for site equipment, systems, and utilities, including providing validation input for site Change Controls.
- Work with the validation specialist to ensure equipment periodic reviews and revalidation activities are executed as per the schedule.
- Accountable for review and/or approval of validation activities including FAT / IQ / OQ / PQ / FMEA Risk Assessments.
- Participate in project teams and assist in determining project schedules and the appropriate levels of validation.
- Ensure technical input and guidance on deviation investigations during qualification/validation activities in case of relevance or impact.
- Provide support to the local organization as quality/validation SME
- Write and/or review and approval of functional area documentation (SOPs, Work Instructions, technical reports and protocols)
- Lead and/or participate in quality risk assessments and provide quality oversight to ensure risk assessments are effectively maintained/ controlled.
- Ensure non-conformances/deviations/complaints are investigated and assessed for root cause and identification and closure of effective CAPA’s
Essential Role Requirements:
- Minimum of a bachelor’s degree in science, Engineering, Technology, or a related discipline.
- Relevant experience as a QA validation engineer/specialist in a cGMP environment (3+ years).
- Full understanding of cGMP requirements including Annex 11 and Annex 15.
- Effective technical writing skills.
- Experience of working in an aseptic manufacturing environment is desirable.
- Good problem solving and investigation skills.
- Good professional standards, meticulous and demonstrates good attention to detail.
- Ability to work under pressure and meet deadlines.
- Highly motivated self-starter and team worker.
- Ability to work in a team-based environment and ability to manage a wide range of specific tasks.
- Good organisational, coordination and communication skills.
Duration: 4 months
Location: Galway – Role can be completed remotely.