Specialist Computerized Quality Systems

Werkgever CheckMark Labrecruitment
Plaats Regio Leiden
Provincie Zuid-Holland
Dienstverband Voltijd (> 36 uur)
Contract Tijdelijk
Plaatsingsdatum vrijdag 29 december 2017
Sluitingsdatum vrijdag 26 januari 2018

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Functieomschrijving

You act on the interface of IT and quality assurance. you are responsible for GMP-level computerized quality systems, ensuring that the these systems are fit-for-use, compliant, and state-of-the-art technology. We are not looking for a extensive programming experience, but rather expertise in implementation of designed systems, communication and project management.

As Specialist Computerized Quality Systems you are reponsible for the computerized systems, making sure that they are fit-for-use and alignmed with company and regulatory quality standards. Being not a programmer, but a project manager and good listener, you ensure that several needs are met.

- The department is responsible for the maintenance of the GMP compliance standards, for the release of raw materials and products, for the review, approval and archiving of the GMP documentation and data integrity 
- You take the lead in, or are part of, local and global initiatives and projects. You test and implement new functionalities adn are responsible for maintenance of masterdata and documentation and training is organized at site level
- Moreover you handle quality assurance and compliance aspects of these projects such as events, change controls, document review and training management. This inculudes development of training modules
- Act as single point of contact for global teams and local business- and end users. Provide support to the end users, resolves issues, and performs troubleshooting
- You maintain a network in order to be aware of the latest developments and best practises in this field.
- The complexity  or challenge lies in the fact that you operate in a complex, multi-functional, and multi-site environment, where continuous improvement of the core Computerized Quality Systems is required

Profiel

Opleiding HBO
Ervaring Ervaren (3 - 8 jaar)
As Specialist Computerized Quality Systems you have the following qualifications and experience:

- Minimum of Bachelor degree or equivalent in computer science or equivalent; supplemented with additional training or experience during work life.
- Work experience for 5 years, of which minimum 2 years relevant to this role. You acuired this experience in the Pharmaceutical or related industry and are thus familliar with quality standards that apply
-  Experience in a complex, multinational work environment/company.as un particular external contacts require tact and diplomacy
- 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.
- You are a self-starter,with planning skills, and have ability to prioritize multiple commitments.

Aanvullende informatie

- Secondment via Checkmark Labrecruitment of approximately 6 months. 
- Intention to takeover by the company after this assignment
- Minimal of 32 hours per week. Preferably full-time

Contact

Neem voor meer informatie contact op met  Coen Smiers: 0182 590 218 // 06 218 999 66
Vacaturenummer: 5567

Bedrijfsprofiel

A large biopharmaceutical company

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