QC Analyst (Inhalation Experience)

Industry : Pharmaceutical

Role Summary:

  • Technical Laboratory SME with experience representing company in regulatory audits (i.e. front room experience responding to FDA / HPRA audit queries).
  • Detailed understanding of Inhalation product testing requirements.
  • Ability to translate knowledge on Inhalation product testing to the site’s laboratory testing program.
  • Supports Laboratory Set-up activities.
  • Prepares Laboratory procedures, specifications, protocols & reports as required.
  • Performs Laboratory testing and investigations per SOP, applicable regulations and cGMP.
  • Performs peer review of documentation as required.
  • Performs Analytical method verification, validation and technical transfer as required.
  • Supports Laboratory/Site EHS governance.
  • Performs management of Laboratory consumables ordering and tracking.
  • Assists in Equipment Qualification activities, ordering and tracking as required.
  • Supports Laboratory colleagues on a day-to-day basis.
  • Supports preparation for regulatory audits/visits and ongoing audit readiness.
  • Supports development of QC Testing processes.
  • Liaises with CROs and audits where appropriate.
  • Other activities as per the requirement of Laboratory Manager.
  • Ensure all required training has been carried out to ensure that procedures are followed and meet all quality requirements.
  • Report problems with quality, processes and materials to the HOD.
  • Required to operate in compliance with company Policies, Procedures and Guidelines, regulatory requirements as applicable and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable work functions.

Location:  Tipperary

Contract: 12 Months

To apply for this job email your details to enquiries@qaresources.com.