QC Analyst (Inhalation Experience)

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