Engineer
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.
In this role you will support the primary process by completing Non-Conformances, managing CAPA’s including root cause analysis, manage change controls, audit observations and revising SOPs. You will improve the quality and performance of the primary production process by identifying and implementing (continuous) improvements initiatives and you will manage Projects of moderate complexity.
· Work within full GMP compliance
· Own NCs , CAPAs, CAPA-EVs and Change records
· Perform (comprehensive) NC investigations and CAPA actions
· Effectively manage CAPA and Change Controls
· Ensure timely closure of owned records
· Execute, investigate, determine and implement responses related to audit observations
Improve quality and performance
· Collect relevant information from other departments
· Help to ensure integrity of available data
· Make information available to the department and supporting departments
· Develop and Assist in the roll-out / implementation of new concepts
· Take the Lead and Participate in Continuous improvements initiatives (Lean)
· Become actively involved in / lead root cause investigations of complex operational issues
Project management
· Participate in / lead assigned internal projects of moderate complexity
· Complies with Corporate Project management guidelines and deliverables
· Oversees and controls milestones
· Minimum 3 years of related experience in an industrial environment
· Experience in a pharmaceutical / GMP environment
· Knowledge and understanding of Good Manufacturing Practices
· Experience in writing procedures
· Fluent in Dutch and English, both spoken and written
Preferred Requirements
· Proven implementing skills
· Experience MS Office
· Experience in analysis and reporting techniques
· Experience with Six Sigma / LEAN / Operational Excellence principles
· Insight in qualification / validation approach / strategy
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jorien van Es.
The Company
A leading Pharma/biotechnology company who's mission is to discover and innovate medicines for patients with serious illnesses.Role Description
This role supports the process development engineering area in a broader scope, including compliance records, root cause investigations and project management.In this role you will support the primary process by completing Non-Conformances, managing CAPA’s including root cause analysis, manage change controls, audit observations and revising SOPs. You will improve the quality and performance of the primary production process by identifying and implementing (continuous) improvements initiatives and you will manage Projects of moderate complexity.
Responsibilities
Support primary production process· Work within full GMP compliance
· Own NCs , CAPAs, CAPA-EVs and Change records
· Perform (comprehensive) NC investigations and CAPA actions
· Effectively manage CAPA and Change Controls
· Ensure timely closure of owned records
· Execute, investigate, determine and implement responses related to audit observations
Improve quality and performance
· Collect relevant information from other departments
· Help to ensure integrity of available data
· Make information available to the department and supporting departments
· Develop and Assist in the roll-out / implementation of new concepts
· Take the Lead and Participate in Continuous improvements initiatives (Lean)
· Become actively involved in / lead root cause investigations of complex operational issues
Project management
· Participate in / lead assigned internal projects of moderate complexity
· Complies with Corporate Project management guidelines and deliverables
· Oversees and controls milestones
Requirements
· Bachelor degree (relevant education) or the equivalent combination of education and experience· Minimum 3 years of related experience in an industrial environment
· Experience in a pharmaceutical / GMP environment
· Knowledge and understanding of Good Manufacturing Practices
· Experience in writing procedures
· Fluent in Dutch and English, both spoken and written
Preferred Requirements
· Proven implementing skills
· Experience MS Office
· Experience in analysis and reporting techniques
· Experience with Six Sigma / LEAN / Operational Excellence principles
· Insight in qualification / validation approach / strategy
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Jorien van Es.
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