QA & Validation Specialist / Permanent / Breda Region / Big Pharma
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 and Biotechnology organisation, based in Noord-Brabant Netherlands.
The Technical QA Specialist will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality guidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS).
- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation;
- Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria;
- Project team member to develop efficient quality processes and translate them in standard operating procedures;
- Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
At least 4 years of professional experience within a GMP environment;
Relevant experience with equipment and automation validation;
Knowledge of the Quality Assurance principles;
Able to work on a wide variety of projects simultaneously;
Able to work in a changing environment;
Fluent in English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Martijn van Nieuwenhovensss.
The Company
A leading Pharma/biotechnology company who's mission is to discover and innovate medicines for patients with serious illnesses.Role Description
In this role you will report to the Senior QA Manager and be part of the technical QA team. This team consists of 5 people and is part of the QA organization of 45 people. They keep oversight on introduction and modification of equipment, systems and operations. By controlling the critical aspect of our operations and systems throughout the life cycle, we safeguard the high quality of our medicines. Additionally, we provide quality engineering support for quality investigations and testing strategies.The Technical QA Specialist will be the liaison between quality and engineering to ensure new equipment is introduced within manufacturing conforming quality guidelines. You will work closely together in different project teams with the following departments: Process Development (PD), Maintenance and Engineering (M&E), Production, Information Systems (IS).
Responsibilities
- Agree on the validation strategy and provide guidance regarding design, characterization and validation for equipment and information systems in cooperation with the other departments;- Assure agreed validation strategy is properly documented and aligned with procedural and regulatory requirements by reviewing and approving validation documentation;
- Provide support to Plant QA regarding equipment or information system related production issues. You provide quality engineering support to establish appropriate sampling plans and acceptance criteria;
- Project team member to develop efficient quality processes and translate them in standard operating procedures;
- Perform final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
Requirements
Master degree in engineering or pharma;At least 4 years of professional experience within a GMP environment;
Relevant experience with equipment and automation validation;
Knowledge of the Quality Assurance principles;
Able to work on a wide variety of projects simultaneously;
Able to work in a changing environment;
Fluent in English.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Martijn van Nieuwenhovensss.
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