Harmonics Recruitment are currently recruiting for 2 x QC Analysts for our MNC client on a 12 month contract basis.
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 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