GMP Specialist Senior/ QA (project 9 months)
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 Zuid-Holland Netherlands.
• You make sure the GMP Quality Processes adhere to the applicable GMP regulations
• You make sure the GMP Quality Processes are consistent within the organization through internal audits, gap assessments, and risk assessments.
• You are a key contact for GMP Compliance and/or training topics
• You provide GMP advice to improvement projects and you have an active role in the implementation of such projects.
• You organize and support Health Authority inspections, 3rd party inspections, and Headquarters audits.
• You are Quality approver for improvements identified during inspections and audits.
• You make sure Performance, Quality, and Compliance reviews are generated.
• Minimum 4 years of pharmaceutical or related industry work experience, of which a substantial part in quality or compliance functions.
• Knowledge of GMP regulations and preferably knowledge of automated systems and/or validation.
• Able to translate complex situations to simple, practical solutions.
• Preferably experience with Lean tools.
• Excellent communication and advisory skills both in English and Dutch.
The Company
The client is driven by the commitment to patients, the client brings innovative products, services and solutions to people throughout the world.Role Description
The department Quality Systems & Compliance is responsible for (the improvement of) the compliance status within the company. The main focus areas are: Inspection readiness, Internal auditing, GMP (Good Manufacturing Practices) training, Management review, CAPA management, Quality metrics, and Compliance gap assessments. We work closely together with the GMP departments and associated companies worldwide.The department consists of 8 employees, of which 5 (Sr) GMP Specialists.Responsibilities
• You are responsible for one or more focus areas within the department.• You make sure the GMP Quality Processes adhere to the applicable GMP regulations
• You make sure the GMP Quality Processes are consistent within the organization through internal audits, gap assessments, and risk assessments.
• You are a key contact for GMP Compliance and/or training topics
• You provide GMP advice to improvement projects and you have an active role in the implementation of such projects.
• You organize and support Health Authority inspections, 3rd party inspections, and Headquarters audits.
• You are Quality approver for improvements identified during inspections and audits.
• You make sure Performance, Quality, and Compliance reviews are generated.
Requirements
• Master degree or equivalent in biosciences, pharmacy or equivalent.• Minimum 4 years of pharmaceutical or related industry work experience, of which a substantial part in quality or compliance functions.
• Knowledge of GMP regulations and preferably knowledge of automated systems and/or validation.
• Able to translate complex situations to simple, practical solutions.
• Preferably experience with Lean tools.
• Excellent communication and advisory skills both in English and Dutch.
Prosimy o aplikowanie poprzez przycisk znajdujący się po prawej stronie ogłoszenia.
