QA/Validation Specialist (Contract Role)

Industry :  Healthcare

Role Responsibilities:

  • 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.

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