Computer Systems Validation Lead

Job description

Computer Systems Validation Lead(Vacaturenummer:00000UHY)OmschrijvingCrucell, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is dedicated to bringing meaningful innovation to global health. Our teams focus on the discovery, development, manufacture and marketing of vaccines and antibodies to protect people worldwide from infectious diseases.
In our organization entrepreneurial people are working in a dynamic culture in which innovation and a 'can do' state of mind are the central points. In order to strengthen our team we are continuously looking for enthusiastic, talented people who have the ambition to develop themselves and can be of value to Janssen.
For our department we are currently seeking for a Computer Systems Validation LeadDepartment/Project:Global Quality Operations and ComplianceJob Description:
- Provide compliance leadership, direction and oversight to project teams in the area of Computer System Validation.
- Responsible for the quality oversight of GxP regulated computerized systems (e.g. manufacturing plant systems, laboratory systems and enterprise applications).
- Manage the release of regulated systems for GxP production use.
- Participate in the review and approval of technical changes, Quality Incidents, CAPA’s and procedures.
- Contribute to establishing and deploying processes, compliance-driven standards, and procedures (as required), determining boundaries for harmonization and alignment versus differentiation, and ensuring they remain current with FDA and global regulatory requirements for GxP computerized systems.
- Participate in evaluating the current Crucell quality systems for GxP computerized systems, and implement improvements to comply with the current FDA/EU standards.
- Provide quality guidance on GxP regulatory requirements (including but not limited to 21 CFR Parts 210, 211, 58, 820, 11 and EU Annex 11 EU).
- In addition, this individual will lead and participate in project teams and may participate in regulatory inspections and client audits.
KwalificatiesMinimum Qualifications:
- Bachelor’s or Master degree in science, computer science, or relevant area
- English, fluently spoken and written
- Thorough knowledge of cGMP, in manufacturing and R&D within GxP regulated industries
- A minimum of 7 years relevant working experience in a pharmaceutical or biotechnology company of which preferably 3 years in validation or QC, and in QA/CSV
- In-depth knowledge of computerized quality systems
- Experience with GMP inspectionsCompetences:
- Communicative skills
- Negotiation skills
- Convincing
- Team player
- Accuracy
- Problem solverTravel
- May require 20% international travelWill you be our new colleague? Please apply onlinePrimaire locatie: Europa/Midden-Oosten/Afrika-Nederland-Zuid Holland-LeidenOrganisatie: Crucell Holland BV (7328)Functie: Validation