QMS Specialist (Leiden)

Location: Netherlands

SIRE 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 Pharmaceutical organization, based in Zuid-Holland Netherlands.

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 Quality Assurance department has a vital position in the organization. The department is responsible for the maintenance of the compliance standards, for the release of raw materials and products, for the review, approval and archiving of the GMP documentation and for training. The automation of Quality Systems is of growing importance in the Quality processes. Testing, implementation of new functionalities, maintenance of masterdata and documentation and training is organized at site level. The need for Computerized Quality Systems in the field of Event, Change Control, Document and Training management is instrumental for pharmaceutical companies.

RESPONSIBILITIES

- Acts as a Center of Expertise for GMP Computerized Quality Systems. Maintains and improves GMP Computerized Quality Systems, ensuring that the Computerized Quality Systems are fit-for-use, compliant, and state-of-the-art technology.
- Is responsible for all project aspects of Computerized Quality Systems improvement initiatives and application updates. Project lead for local Quality Systems initiatives.
- Is project member in projects initiated by the global Computerized Quality Systems organization and responsible for site/regional implementation and roll out. clients standards for regulatory compliance, e.g. on Data Integrity.
- Acts as single point of contact for the Global Computerized Quality Systems teams and local business- and end users.
- Maintains a relevant network of contacts with Computerized Quality Systems specialists within the clients companies, but also with other pharmaceutical companies and professional associations
- Is responsible for the consistency in use of the Computerized Quality Systems across processes and departments.
- Defines the skill requirements and develops training programs for Computerized Quality Systems for end users.
- 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.
- Ensures that the performance of the system meets regulatory and the clients standards by developing and performing periodic verification
- Ensures good communication with all departments and functional groups

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.
- 40 h / week available, 32 h / week is discussable

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Laura Hoekstra.