Csv Consultant

CSV Consultant

**Experis is the global leader in professional resourcing and project-based workforce solutions.**

**For our client, a leading Pharmaceutical company in Bern, we are looking for a CSV Consultant.**

**Location: Bern**

**Duration of contract: 9 months**

**Responsibilities**

You will be in charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:

- Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
- Validation Master plans are up to date and established for all ongoing projects

**Essential duties**
- Assess and produce the CSV package(s) on an assigned project. Taking accountability for the work to be produced.
- 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)
- Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
- Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems
- Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
- Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems commissioning, and qualification process are assessed and resolved.
- Performance measurement
- Delivery on annual goals & objectives, guided by Our Credo and Leadership Imperatives

**Education & Experience**
- 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
- Experience on defining strategy and 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

**Skills & Competences**
- Excellent communication skills
- Analytical thinking and problem-solving ability
- Ability to work under mínimal supervision; Assess priorities and work well under pressure in a fast-paced environment
- Ability to effectively work as part of a multidisciplinary, international team
- Business fluency in English
- German language is a plus
- Basic know-how of Qualification requirements according to cGMP regulations
- Basic know-how of quality assurance principles

A minimum of 3 days per week of site presence is required.
Due to the nature of the position and the tasks to be performed, it may be required to be more than 3 days per week on site, based on demand. Therefore, living in a regular commutable distance from Bern
- Bumplitz is advisable.

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Elaine Kanwar at +41 61 282 22 23