Aktuelle Jobs im Zusammenhang mit Csv Consultant - Bern, Bern - Experis
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CSV Specialist
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Bern, Bern, Schweiz Avacone Iberia S.L. VollzeitJob Title: CSV ConsultantWe are seeking a skilled CSV Consultant to join our team at Avacone Iberia S.L.Key ResponsibilitiesThe successful candidate will be responsible for:Managing and executing CSV projects for customers in the life science sectorEvaluating and creating gap analyses, CSV documents, and data governanceEnsuring compliance with relevant...
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Csv Consultant
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Bern, Schweiz Experis VollzeitCSV 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)...
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CSV Consultant
vor 3 Wochen
Bern, Schweiz Avacone Iberia S.L. VollzeitWe are looking for motivated colleagues to join our team.What you will doManagement and operational execution of CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.Evaluation and creation of gap analyses, CSV documents and data governanceEnsuring compliance with the relevant regulations with a focus on data...
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CSV Consultant
vor 1 Woche
Bern, Schweiz Avacone Iberia S.L. VollzeitWe are looking for motivated colleagues to join our team.What you will doManagement and operational execution of CSV projects for customers in the area of GxP Compliance, Commissioning & Qualification or QA Services.Evaluation and creation of gap analyses, CSV documents and data governanceEnsuring compliance with the relevant regulations with a focus on data...
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Cqv / Csv Consultant
vor 4 Wochen
Bern, Schweiz Consultys VollzeitAs part of our development, we are recruiting a CQV/CSV Consultant to join our teams. - Assess laboratory instruments and software for their compliance with Data Integrity guidelines. - Implement Data Audit Trail Reviews for laboratory instruments and software in accordance with client guidelines. - Manage local and global qualification and validation...
Csv Consultant
vor 3 Monaten
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 fastchanging 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 (eg: servers, network and software services)
- A minimum of 4 years of working experience with CSV
- Knowhow 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 problemsolving ability
- Ability to work under mínimal supervision; Assess priorities and work well under pressure in a fastpaced environment
- Ability to effectively work as part of a multidisciplinary, international team
- Business fluency in English
- German language is a plus
- Basic knowhow of Qualification requirements according to cGMP regulations
- Basic knowhow of quality assurance principles
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.
