Team Leader Quality Assurance
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 Pharmaceutical organisation, based in Limburg Netherlands.
You also will be responsible for planning and execution of daily quality assurance while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.
Monitor compliance with all applicable GMP and safety standards in the area of quality assurance.
Support the Qualified Person in his role, including audits and quality training.
Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.
Suggest training activities.
Involved in planning activities in cooperation with the Manager QA / Director Quality
Provide guidance to (senior) QA Officers.
Plan and execute quality assurance activities (document management, batch record and label issuance, batch record review, equipment and supplier qualifications) including documentation.
Prepare data for trending (QRB, Annual Product Review) and support and attend internal and external audits.
- Good knowledge of continuous improvement
- Excellent relationship manager, influencer and communicator.
- Experience in project management and technical writing.
- Profound knowledge of Microsoft Office Programs and SAP
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
You will be leading a team of (Senior) Quality Assurance Officers on execution of quality assurance activities and you will be the main link between the team and the QA DirectorYou also will be responsible for planning and execution of daily quality assurance while ensuring compliance with international quality requirements as defined by the applicable guidelines (e.g. FDA, EMA, ICH) and all existing GMP standards in the area of responsibility.
Responsibilities
Suggest process improvements and actively follow up improvement programs.Monitor compliance with all applicable GMP and safety standards in the area of quality assurance.
Support the Qualified Person in his role, including audits and quality training.
Write, review and approve documentation (SOP’s, manufacturing and quality instructions, validation of protocols and reports, non-conformities, change requests). Handle, distribute and archive controlled documents.
Suggest training activities.
Involved in planning activities in cooperation with the Manager QA / Director Quality
Provide guidance to (senior) QA Officers.
Plan and execute quality assurance activities (document management, batch record and label issuance, batch record review, equipment and supplier qualifications) including documentation.
Prepare data for trending (QRB, Annual Product Review) and support and attend internal and external audits.
Requirements
- Minimum Bachelor degree in Science or similar qualification (Cosmetic, Food or Pharma) .- Good knowledge of continuous improvement
- Excellent relationship manager, influencer and communicator.
- Experience in project management and technical writing.
- Profound knowledge of Microsoft Office Programs and SAP
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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