Quality Assurance Manager
Location: NetherlandsSIRE® 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 organisation, based in Noord-Brabant Netherlands.
Support in maintaining the Quality Management System
Maintenance of an adequate Quality Management System, eQMS user support and management of intra-company Quality Agreements;
Perform and participate in internal/external audits;
Support the management of complaints, quality issues and recalls;
Monitor and report Quality KPI’s for the region and support Quality System Management Reviews;
Implement local continuous process excellence and improvement activities
Support new product launches;
Manage local and regional projects.
3-5 years Pharmaceutical industry experience in various local and/or global Quality and ideally manufacturing or supply chain roles roles;
Understanding of Pharmaceutical GxP processes and regulatory requirements
Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion;
Experience with building and implementing lean processes in full compliance with regulatory requirements;
Computer literate, the role holder will need to work in standard office software, SAP, eQMS and any other systems necessary to complete the activities required;
Fluent in written and spoken English
Ability to communicate effectively through verbal and written media;
Ability to interact with personnel of all levels
Excellent organizational, interpersonal, influencing and listening skills;
Ability to travel according to business needs
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
In this role you will be responsible for the CEMEA region regarding quality mattersResponsibilities
Responsible for operational QA activities including deviations, temperature excursions, CAPAs and changes;Support in maintaining the Quality Management System
Maintenance of an adequate Quality Management System, eQMS user support and management of intra-company Quality Agreements;
Perform and participate in internal/external audits;
Support the management of complaints, quality issues and recalls;
Monitor and report Quality KPI’s for the region and support Quality System Management Reviews;
Implement local continuous process excellence and improvement activities
Support new product launches;
Manage local and regional projects.
Requirements
BS, Masters or Ph.D. preferably in life sciences3-5 years Pharmaceutical industry experience in various local and/or global Quality and ideally manufacturing or supply chain roles roles;
Understanding of Pharmaceutical GxP processes and regulatory requirements
Ability to drive and manage issues, complaints, CAPAs and changes through to satisfactory conclusion;
Experience with building and implementing lean processes in full compliance with regulatory requirements;
Computer literate, the role holder will need to work in standard office software, SAP, eQMS and any other systems necessary to complete the activities required;
Fluent in written and spoken English
Ability to communicate effectively through verbal and written media;
Ability to interact with personnel of all levels
Excellent organizational, interpersonal, influencing and listening skills;
Ability to travel according to business needs
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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