QS 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 Belgium.
· the continuous improvement plan is implemented
· the facilities / equipment’s / systems are properly validated / qualified acc. GMP guidelines
Provide quality guidance for the development of the validation approach
Actively contribute to continuous improvement plan:
Developing and implementing a Quality System based on Business process approach
Managing Operational Excellence initiatives
Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
Assure requirements traceability throughout the whole project validation file
Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.
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
s part of his/her role the Quality Systems Manager will ensure:· the continuous improvement plan is implemented
· the facilities / equipment’s / systems are properly validated / qualified acc. GMP guidelines
Responsibilities
Ensure the review/approval of documentation pertinent to equipment /systems validation/ qualification is timely performed to achieve compliance to procedures and regulatory requirements.Provide quality guidance for the development of the validation approach
Actively contribute to continuous improvement plan:
Developing and implementing a Quality System based on Business process approach
Managing Operational Excellence initiatives
Collaboration and participation in projects as Quality Representative for equipment / systems validation / qualification.
Assure requirements traceability throughout the whole project validation file
Manage the requalification plan to maintain the accurate validation / qualification state of facilities and systems.
Requirements
o 8 years experiences with 3 years in an operational role in a GMP environmento 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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