Senior Manager QA / Plant Manager QA
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 Noord-Brabant Netherlands.
- Ensure on time resolution of non-conformances
- Establish and maintain effective working relationships with Production, Maintenance and Warehouse/Distribution staff
- Ensure that Quality policies, procedures and programs are properly implemented in daily GxP operations
- Participate in internal and external audits and projects as required
- Provide guidance and direction to Quality, Production, and M&E staff with regards to compliance
- Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements
- Consolidate and report team performance metrics and drive continuous improvement activities
- At least 10 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits
- At least 5 years of supervisory experience
- Deep understanding of GMP guidelines
- Extensive knowledge of warehouse and manufacturing processes and operations
- Extensive knowledge of GxP change control, investigations, validation and training requirements
- Fluent in Dutch and English language
The Company
A leading Pharma/biotechnology company who's mission is to discover and innovate medicines for patients with serious illnesses.Role Description
As the Senior Manager Plant QA you are responsible to lead and motivate the QA team. You play a key role in the clients mission to serve patients with high quality medicines. While ensuring Quality and Compliance, you also assume responsibility to implement LEAN methodology into the QA processes, to support future growth and changing business needs.Responsibilities
- Are responsible for disposition of all non-clinical materials- Ensure on time resolution of non-conformances
- Establish and maintain effective working relationships with Production, Maintenance and Warehouse/Distribution staff
- Ensure that Quality policies, procedures and programs are properly implemented in daily GxP operations
- Participate in internal and external audits and projects as required
- Provide guidance and direction to Quality, Production, and M&E staff with regards to compliance
- Partner with Production staff in performing risk analysis and the establishment of quality limits and requirements
- Consolidate and report team performance metrics and drive continuous improvement activities
Requirements
- Pharmacist Qualification or related education- At least 10 years of related Quality Assurance experience in the pharmaceutical or medical device industry with progressively increasing responsibility and demonstrated experience in investigations, change control, validation and/or audits
- At least 5 years of supervisory experience
- Deep understanding of GMP guidelines
- Extensive knowledge of warehouse and manufacturing processes and operations
- Extensive knowledge of GxP change control, investigations, validation and training requirements
- Fluent in Dutch and English language
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