Quality Systems Manager
Location: BelgiumSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Waals-Brabant Belgium.
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
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 Seppe Verhoeven.
The Company
.Role Description
The 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 inspectionsResponsibilities
o Developing and implementing a Quality System based on Business process approacho 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
Requirements
o Engineering degreeo 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 Seppe Verhoeven.
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