QA/RA Specialist Pharmaceuticals
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.
- Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection)
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
- Provide training to affiliate staff on complaint handling procedures and performing investigations/assessments
- Initiate and own QA Non Conformances/CAPAs as needed
- Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
- MBO or Bachelor’s degree or equivalent
- Typically 3 or more years of related professional experience
- Fluent in English language.
OR
- Master’s degree or equivalent
- Minimal related professional experience
- Fluent in English language.
Preferred Requirements
Experience in Quality Assurance, including handling product complaints investigations
Experience in pharmaceutical industry
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Turlough White.
The Company
Part of an international organisation, specialising in the production of APIs, Drug Products, and associated Packaging Services. A dedicated professional team ensure the highest standards are pursued at all stages of development. Combined with a vertically-integrated supply chain model that provides development & manufacturing expertise spanning the complete GMP, translating into high-value products.Role Description
As a Quality Assurance Specialist you will join the product complaints and surveillance department which is in charge of performing the necessary investigations for commercial and clinical products.Responsibilities
- Initiate and own product quality complaints, Safety quality investigations and product security investigations- Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection)
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
- Provide training to affiliate staff on complaint handling procedures and performing investigations/assessments
- Initiate and own QA Non Conformances/CAPAs as needed
- Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required.
Requirements
Minimum Requirements- MBO or Bachelor’s degree or equivalent
- Typically 3 or more years of related professional experience
- Fluent in English language.
OR
- Master’s degree or equivalent
- Minimal related professional experience
- Fluent in English language.
Preferred Requirements
Experience in Quality Assurance, including handling product complaints investigations
Experience in pharmaceutical industry
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Turlough White.
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