Role DescriptionThe Quality Systems Manager will be part of the Quality Assurance Department and will report into the Head of Quality. Under the direction of the reporting manager, he /she will continuously improve Compliance systems, strengthen quality awareness and investigate quality issues using applicable process improvement and problem solving techniques to assure successful outcomes of Company and external Health Authority inspections
Responsibilitieso Developing and implementing a Quality System based on Business process approach o Managing Operational Excellence initiatives · Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems. · Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification. · Provide quality guidance for the development of the validation approach. · Assure requirements traceability throughout the whole project validation file · Ensure the review/approval of documentation pertinent to equipment /systems validation/ qualification is timely performed to achieve compliance to procedures and regulatory requirements.
As member of the Quality department : o Evaluation / Approval of deviation and support to related investigations o Operate the change control system (risk assessment, assessment of validation / qualification needs ; follow up ) o Operate the CAPA system o Work with relevant departments to ensure timely closure of quality actions / findings o Perform inspections/internal audits and provide quality oversight for the inspection/ audit program o Collaborate with operations to resolve compliance matters
Requirementso Engineering degree o 8 years experiences with 3 years in an operational role in a GMP environment o Very good knowledge of GxP in a regulated environment o Knowledge of risk assessment / validation /quality systems o Excellent accuracy and attention to detail o Excellent interpersonal skills o Strong problems solving skills, issue resolution and root cause analysis o Highly Flexible and Adaptable. Able to work independently in a fast paced multitasking environment o Working knowledge of computer packages o Knowledge of Quality Software Systems( Trackwise , Lab software ,…) is an asset o Language : English , French
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Greg Silberstein.