Norgine एक यूरोपीय विशेषज्ञ फार्मास्युटिकल कंपनी है, जिसका इतिहास 1906 तक जाता है। इसकी टीम वैश्विक साझेदारियों के नेटवर्क के माध्यम से दवाओं का अधिग्रहण, विकास और व्यावसायीकरण करती है, जिसमें गैस्ट्रोएंटरोलॉजी और हेपेटोलॉजी की विशेष विशेषज्ञता है। कंपनी के उत्पाद हर वर्ष दुनिया भर में लगभग 2.5 करोड़ मरीजों तक पहुँचते हैं। इस कार्य को 1,400 से अधिक कर्मचारी और 500 मिलियन यूरो से अधिक की शुद्ध उत्पाद बिक्री का समर्थन प्राप्त है। Norgine लाइसेंसिंग, अधिग्रहण और विशेष प्रयोजन संस्थाओं के माध्यम से साझेदारों के साथ काम करती है और भविष्य की दवाओं के विकास में पुनर्निवेश करती है।
Computer Systems Validation Engineer (12-Month Contract) at Norgine
Support validation of Norgine’s regulated computer systems, helping maintain GxP compliance and data integrity. Apply risk-based validation practices across systems and their lifecycle.
विवरण
- Plan and deliver validation for new and existing GxP-regulated computerised systems.
- Prepare and maintain validation plans, risk assessments, protocols, test scripts, reports and traceability matrices.
- Test and verify systems against business, quality and regulatory requirements.
- Provide validation evidence for audits, inspections and regulatory enquiries.
- Partner with Quality, Manufacturing, Engineering, IT and vendors to assess changes and incorporate validation throughout the system lifecycle.
- Improve validation standards, processes and practices.
- Help maintain compliance of Norgine’s regulated systems, equipment, validation records and related processes with applicable quality and regulatory requirements.
- Provide lifecycle validation expertise and use risk-based methods to support compliance, data integrity and operational effectiveness.
आवश्यकताएँ
- Bachelor’s degree or equivalent qualification or experience in computer systems, engineering or a related field.
- Experience using relevant procedures or systems.
- Skills in quality assurance methods, review and reporting, data collection and analysis, planning, requirements verification and project quality management.
- Ability to interpret complex information, make sound decisions and determine appropriate actions.
- Strong communication and teamwork skills, including confidence to raise compliance concerns when needed.
- A structured and accountable approach to documentation, testing and delivery.
- Working knowledge of GxP and data integrity principles, including GAMP 5, EU GMP Annex 11 and 21 CFR Part 11 guidance.
- Experience preparing and executing validation documents such as risk assessments, protocols, test scripts and validation reports.
- Familiarity with regulated computerised systems in manufacturing, laboratories, quality, ERP, MES or LIMS.
लाभ
- Ongoing professional development in a supportive, inclusive workplace.
- Career development opportunities.
- Work that contributes to improving patients’ lives.
- Benefits vary by location; ask the Norgine Talent Acquisition representative for details.