Senior Business Quality Assurance Manager Computer Systems (m/f/d)

REFERENCE NUMBER:

453955/1

MY DUTIES:

- Perform quality assurance tasks regarding validation of global computerized systems according to the GMP Inventory and regarding projects (i.e. PT strategic projects and smaller projects)
- Align quality assurance tasks across the organization within the department as well as with other global or local functions
- Provide guidance for local quality departments
- Assure compliance of systems according to the GMP Inventory by providing templates, support in creation of CSV documentation, review and approval of SOPs
- Support Quality Assurance tasks regarding validation of computerized systems, including review and approval of validation lifecycle documents, review and approval of validation reports and release systems according to CSV, approval of change requests and owning discrepancies

MY QUALIFICATIONS:

- Profound experience in the pharmaceutical or biopharmaceutical industry with sound knowledge of cGMPs or equivalent regulations as well as demonstrated expertise with computer system validation and risk management, change control, and discrepancy/CAPA management
- Experience in working in validated or controlled environments and ability to propose pragmatic quality approaches while maintaining full compliance to regulations and standard
- Knowledge of manufacturing, cGMPs and compliance
- Proven experience working with SAP / ERP / Serialization Systems
- Experience working with HP ALM
- High quality orientation with attention to detail; drive for excellence and positive business outcomes
- Demonstrated influencing and interpersonal skills with strong written and verbal communication skills; ability to communicate effectively with all levels of the organization
- Fluent in English

MY BENEFITS:

- International pharmaceutical company
- Project extension planned

ABOUT HAYS:

IT specialists hold all the cards: for its customers in industry and the public sector, Hays is looking for motivated employees who like looking at the bigger picture and growing with new challenges. We make sure that you benefit from our many years of experience in IT recruitment and will find you the right role to suit your skills and interests – all completely free of charge to you. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Nora Holstad Berge

Reference number
453955/1

Contact
E-Mail: [email protected]