QA Specialist
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.
The QA validation specialist will work under supervision of qualified staff. Your level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc). The expectation is that staff can perform selected QA validation activities within one month from starting date.
- Keeps quality oversight on validation strategy and deliverables for specific projects.
- Maintain a close contact and familiarity with Quality systems.
- Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards
and procedures.
- 10 years of professional experience in GMP environment.
- 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging.
- Additional experience with Non Conformances, CAPA’s and Change Control
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
The Company
They are an international company with locations all over the world.Role Description
You will perform QA support and the oversight for equipment, automation and IS validation. This function does not develop the technical solutions.The QA validation specialist will work under supervision of qualified staff. Your level of independency will vary based on familiarity with the subject (e.g. equipment, automation, etc). The expectation is that staff can perform selected QA validation activities within one month from starting date.
Responsibilities
- Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.- Keeps quality oversight on validation strategy and deliverables for specific projects.
- Maintain a close contact and familiarity with Quality systems.
- Provide guidance and direction to Quality, Production, Warehouse/Distribution and Supply Chain staff in regards to compliance with quality policies, standards
and procedures.
Requirements
- Master Degree in Engineering, Pharmaceutical sciences, Process Technology, or equivalent.- 10 years of professional experience in GMP environment.
- 5 years relevant experience in Equipment and Automation Validation, preferably related to secondary packaging.
- Additional experience with Non Conformances, CAPA’s and Change Control
Other information
- 6 months contract with possibility for extensionAre you interested and do want to apply for this role, please fill out your application via the apply button below and contact Windimi Post.
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