QC Analyst_tipperary

CPL

TIPPERARY

Quality Control Analyst. 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 Amneal’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.

1485 days ago