Description The Quality Control Manager will have responsibility to manage, lead and direct a team of QC staff.
The Quality Control Manager will have overall responsibility to manage, coordinate and oversee all QC activities in accordance with site objectives, quality standards and global Zoetis policies, as well as with all relevant regulatory and legislative regulations.
Direct, coordinate and oversee all analytical activities including in-process, release and stability testing of drug substance and drug product materials, as appropriate.
QC release of raw materials and Microbiology testing to support manufacturing schedule.
The QC manager will provide a Leadership role in maintaining the Quality Systems within the Laboratory; ensuring that Standard Operating Procedures are in compliance with cGMP is adhered to at all times.
Support method transfer and validation of bioanalytical methods where required.
The role is also responsible for the initiation, coordination and management of stability studies from registration through to commercialisation.
Oversee and coordinate outsourced testing at third party contract laboratories Duties and directly participating in department personnel recruitment, performance management and training.
• Direct and oversee analytical services performed at Tullamore Site and third party contract laboratories • Budget holder - responsible for resource loading of all projects, developing the op-ex and capex budget requirements and annual strategy plans and monthly reporting of forecast versus actual send • Support analytical methods transfer and validation in conjunction with GMT Analytical group to ensure methods are adequately developed, validated, transferred and maintained • Ensure that testing is performed in an efficient, compliant and timely manner and is assessed against applicable specifications • Provide analytical support with data compilation and review in support of regulatory dossier submissions Ensure laboratory investigations and non conformances are thoroughly investigated and resolved against required timeframes using DMAIC approach • Continuously review quality control processes, procedures and capabilities in order to sustain the most cost-effective processes • Ensure adequate and timely qualification and testing of raw material components and timely QC release of raw materials to support manufacturing schedule.
• Ensure environmental monitoring