:Drive compliance to Quality Management System, by performing batch record reviews - reviewing protocols during the manufacturing process as well as post-production to ensure the quality of the product.
Performing routine audits of logbooks used in the operations/QC areas for completeness and cGMP compliance.Performing final QA review and approval of batch related documentationActive participant in deviation investigations - Process Validation / Equipment Validation documents for example Microbial Mapping validation protocols, resin re-use protocols, cleaning validation protocols, new equipment, etc.QA Approval of quality records including but not limited to; Deviations, Out Of Specifications, CAPAs, Audit findings etc.Review and approval of QA controlled documents within the Quality Management System.Supports compliance to systems timeframes for raising, processing or performing associated tasks ( Change Control actions, DR investigations, processing CAPAs)Issuing protocols as required to other departments.
Perform quality functions including vial thaw, drug substance shipping as requiredUpdating SOP's and other documents to meet current regulatory and corporate standardsServing as a resource to the operational areas on quality related issues.Identification of continual improvement opportunities Conducting Internal AuditsParticipating in Risk AssessmentsAny other legitimate duties requested by QA Manager?Skills and Requirements:Tertiary Academic level in a relevant field (Biotechnology, Biochemistry, Microbiology, Chemistry, Pharmacology, or equivalent).Minimum 3 years of experience in a GMP regulated environment.Preferably, minimum 1 year of experience in Quality Assurance in a GMP regulated environment.Knowledge of pharmaceutical cGMP quality systems and international cGMP regulations and guidelines.Strong communication skills - both written and verbalAdhere to EHS policies and procedures and ensure a safe and healthy workplace environment.Ensure hazardous conditions, hazardous actions, incidents and near-miss incidents are reported.Not knowingly pollute the environment.We offer competitive compensation and benefits packages, along with opportunities for professional growth and development.
If you are a motivated individual with a passion for demand planning and inventory management, we invite you to apply for this exciting opportunity.
Watch as our colleagues explain .Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
