Senior Associate
Location: NetherlandsSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science 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!
THE COMPANY
Our client is a professional Biotechnology and Pharmaceutical organization, based in Noord-Brabant Netherlands.
The company you will be working for is one of the largest Biopharmaceutical companies in the world, located in several countries. Their mission is to expand human life expectancy by developing and creating new ways of treatment.
ROLE DESCRIPTION
In this position you will perform QA support and oversight for equipment, automation and IS validation. In this function you will not develop the technical solutions.
The QA validation specialist will work under supervision of qualified staff. 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
Your responsibilities will be performing review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
Maintain a close contact and familiarity with the company's Quality systems.
You will also provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regards to compliance with quality policies, standards and procedures.
REQUIREMENTS
- University or Bachelor degree in Pharmaceutical sciences, Process Technology, Engineering or equivalent
- 3 years of professional experience in GMP environment
- Relevant experience in Equipment and Automation Validation
- Additional experience with Non Conformances, CAPA’s and Change Control
- Expanding knowledge of GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
- Good attention to detail and excellent writing skills
- Effective communication skills at multiple levels and areas (inside and outside of Quality)
- Good decision making skills and ability to apply risk based approach. Familiar with risk management tools such as FMEA, etc.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .
