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.