Validation Specialist
QLS are recruiting for a Validation Specialist to join a project with a global Pharmaceutical Company based in Bern on a contract basis until the end of the year.
Aim of the position
- In charge of Computer System Validation (CSV) activities forTechnical Services department in order to ensure that: o Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities o Validation Master plans are up to date and established for all ongoing projects
Essential duties
- Assess and lead the CSV package(s) on an assigned project. Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.
- Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts.
- Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
- Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
- Coordination and oversight of external subcontractors / software suppliers
- Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV · Support Technical Services department KPI.
- Ensure the CSV process related procedures and life cycle management are up to date according to international GMP standards and internal procedures
Competencies
- Bachelor/master’s degree in technical or natural sciences
- Ability to work in a fast-changing environment
- A minimum of 3 years of working experience within pharma or a biotech company
- Experienceon validating computerized manufacturing equipment (CSV context)
- Experience on validating software & hardware infrastructure (e-g: servers, network and software services).
- A minimum of 4 years of working experience with CSV · Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
- Excellent communication skills ·
- Ability to work under minimal supervision;
- Business fluency in English Preferred
- German language is a plus
- Experience on validating complex computerized analytical equipment
Apply: Please could you send any correspondence in English. Please quote job reference 00054123 in all correspondence.
