CSV 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 Zuid-Holland Netherlands.
- Is responsible for all project aspects of Computerized Quality Systems improvement initiatives and application updates
- Project lead for local Quality Systems initiatives
- Cooperates with the global Computerized Quality Systems team to develop and maintain the standards for regulatory compliance, e.g. on Data Integrity.
- Provides support to the end users, resolves issues, and performs troubleshooting.
- Defines the skill requirements and develops training programs for Computerized Quality Systems and ensures that appropriate training is given on these systems.
- Ensures that performance, quality and compliance reviews are made, metrics are maintained. Ensures appropriate follow up is done, and information is shared with Site Management.
- Experience in a complex, multinational work environment/company.
- Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization.
- Written and oral communication skills in English. Dutch is preferable.
- Self-starter, planning skills, and ability to prioritize multiple commitments.
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro Active, works independently, takes actions in the absence of specific instruction
- Excellent communication and advisory skills, result oriented.
The Company
Our client is a multinational Pharma company. They are international oriented and work with a high and clear vision. They work together to ensure the quality of life regards to our health.Role Description
Are you a passionate Process Engineer or are you a Computerized quality system expert with a few years of relevant work experience? Do you want a position where you can act as first point of contact? Do you have interest in Lean/six sigma? Then this is the perfect job for you!Responsibilities
You will be responsible to acts as a Center of Expertise for GMP Computerized Quality Systems and as single point of contact. Also you will maintains and improves GMP Computerized Quality Systems, ensuring that the state-of-the-art technology is up tot date. next to that you will be responsible for the following:- Is responsible for all project aspects of Computerized Quality Systems improvement initiatives and application updates
- Project lead for local Quality Systems initiatives
- Cooperates with the global Computerized Quality Systems team to develop and maintain the standards for regulatory compliance, e.g. on Data Integrity.
- Provides support to the end users, resolves issues, and performs troubleshooting.
- Defines the skill requirements and develops training programs for Computerized Quality Systems and ensures that appropriate training is given on these systems.
- Ensures that performance, quality and compliance reviews are made, metrics are maintained. Ensures appropriate follow up is done, and information is shared with Site Management.
Requirements
- Pharmaceutical or related industry work experience for 4-6 years, of which minimum 2-3 years relevant to this role- Experience in a complex, multinational work environment/company.
- Project management skills and interpersonal skills, engaged in contact with personnel at all levels within the organization.
- Written and oral communication skills in English. Dutch is preferable.
- Self-starter, planning skills, and ability to prioritize multiple commitments.
- Analytical thinking and (technical) problem solving. Lean/Six Sigma experience is desirable.
- Pro Active, works independently, takes actions in the absence of specific instruction
- Excellent communication and advisory skills, result oriented.
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