· Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations
· Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
· Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
· Utilise this network to help resolve comments and issues that arise during audit and review.
· Manage product recalls and stock recoveries as appropriate.
· Identify compliance gaps and make recommendations for continuous improvement
· Create and maintain assigned SOPs.
· Perform and review complaints and deviation investigations, change controls and CAPA's.
· Generally follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
· Compile data for reports and presentations, provide data interpretation, draw conclusions.
· Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy and safety in accordance with Company and regulatory requirements.
· Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
· Represents department on cross functional teams.
· Additional activities as assigned by the manager/supervisor
· Degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
· 3 years plus industry experience
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists