Job title: CSV specialist with laboratory expertise
Job type: Permanent
Emp type: Full-time
Industry: Pharmaceuticals / Biotech
Expertise: Quality & Compliance
Skills: CSV qualification experience LIMS device qualification GLP environment laboratory experience
Salary type: Annual
Salary: negotiable
Job published: 2019-04-08
Job ID: 30487
Contact name: Magdalena Chorazy
Phone number: +49 69 348 793 259
Contact email: magdalena.chorazy@hgp.ag

Job Description

CSV Specialist with laboratory expertise

Location: Frankfurt, Germany

HGP Deutschland is seeking for a CSV Specialist with laboratory experience to support our clients in the Frankfurt area.

Your tasks

You will be responsible to support the deployment of Computer System Validation (CSV) projects for Life Science clients in Germany. This position may also provide daily operational support, administration and management for these systems, as well as system enhancements and upgrades.

In this role you will be working in accordance to the client’s Computer Systems Validation policies and procedures to ensure that all projects are implemented in a quality manner, in compliance with appropriate regulations and guidelines (EU GMP Annex 11, OECD No. 15 and 17, 21 CFR Part 11, 58, 210/211). 

Responsibilities include:

  • Providing consultancy and advice to the pharmaceutical industry with focus on:
  • Validation of computerized systems including development of methodology according to GAMP5 risk-based approach.
  • Ensuring full compliance to regulatory, quality, and best practice standards.
  • Provide strategic consulting for Computer System Validation.
  • Integration of equipment qualification into validation strategy.

Our requirements

  • Degree (or similar) in IT, Engineering or Science.
  • 3+ years of experience in CSV (Computer system validation) in highly regulated industries.
  • Experience in Validation, Qualification and Documentation.
  • Experience in GLP and/or GMP environment.
  • Preferably LIMS and/or MES experience.
  • Knowledge of relevant guidelines and regulations.
  • Fluent English & German is a must.

What we offer

  • An attractive remuneration model.
  • Career opportunities in a quickly growing international consultancy firm.
  • Independence in shaping the strategy, with full management support when needed.
  • Consulting roles for international Pharma and Life Science clients in strategically relevant projects.
  • Work in a professional consultancy environment within a highly motivated team.
  • The opportunity to take on responsibility and to help shape our organization.

Who we are

Halfmann Goetsch Partner AG are a business consultancy specializing in Life Sciences. We are global partners for Digital Transformation and Compliance in the pharmaceutical industry. Our consultancy services include Information Risk Management, Data Privacy (GDPR), Data Integrity, Computer System Validation (CSV), MES, GMP, Serialization and Audit Readiness.

HGP is based in Switzerland, with regional headquarters in Germany (Frankfurt), Singapore and Indonesia as well as a recruitment branch, HGP Life Path. Our international approach with sites in strategically important pharmaceutical industry locations enables us to carry out global projects with the necessary expertise and presence.

Our clients are global corporations, small and medium enterprises, manufacturers and suppliers in the following fields: pharmaceutical and bio-pharmaceutical industry, medical devices, manufacturers of packaging machinery, processing equipment and software providers for the pharmaceutical industry.

www.hgp.ag

If you are interested, please contact Magdalena Chorazy, Recruitment Consultant in HGP Life Path. You can call me on +4969348 793259 or send your CV to magdalena.chorazy@hgp.ag

Apply with indeed Apply with linkedin
File types (doc, docx, pdf, rtf) size up to 5MB
File types (doc, docx, pdf, rtf) size up to 5MB