CSV Specialist at HGP Asia- permanent position in Singapore
Location: Singapore based
This role is responsible to support the deployment of Computer System Validation (CSV) projects for international Pharma and Life Science clients. The various IT projects and systems include ERP (Enterprise Resource Planning Systems), MES (Manufacturing Execution System), Data Historian, PLC / SCADA, DCS (Distributed Control Systems such as Emerson DeltaV, Siemens Simatic PCS 7), LIMS (Laboratory Information Management System) and CDS (Chromatography Data System). This position may also provide daily operational support, administration and management for these systems, as well as system enhancements and upgrades.
In this role the CSV Specialist will work 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.
- Manage CSV projects in regulated environments.
- Generate, review and approve CSV documents.
- Support project management activities, identify and pro-actively manage project risks.
- Ensure full compliance to regulatory, quality, and best practice standards.
- Provide strategic consulting for Computer System Validation
- Analyse business needs, propose solutions and assist in user’s requirements gathering.
- Perform technical system development, technical configurations and system testing, where appropriate.
Professional Skills and Experience:
- Degree (or similar) in IT, Engineering or Science.
- 2+ years’ experience working in GxP environment.
- 2+ years’ experience working on CSV projects.
- Excellent written and verbal communication skills.
- Strong organizational and project management skills.
- Familiar with compliance requirements (FDA, EMA, GxP, GAMP 5, 21 CFR Part 11, PICs, etc.).
- Experience in implementing any of the following systems will be an added advantage: ERP (Enterprise Resource Planning Systems), MES (Manufacturing Execution System), Electronic Batch Records, Information Management Systems, Data Historian, PLC / SCADA, DCS (Distributed Control Systems), LIMS (Laboratory Information Management System) and CDS (Chromatography Data System)
- 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.
- Excellent career development and growth opportunities.
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.
If you are interested, please contact Magdalena Chorazy, Recruitment Consultant in HGP Asia. You can call me on +4969348 793259 or send your CV to email@example.com
Key words: CSV, Singapore, permanent, Computer System Validation, GxP, phamra, medical devices, biotech