IT Validation Coordinator in Pharma
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a detail-oriented and analytical IT Validation Coordinator to join our pharmaceutical team in Bengaluru this role you will be responsible for coordinating and overseeing IT validation activities to ensure compliance with industry regulations and standards.
- Develop and implement IT validation strategies and plans for computer systems and equipment used in pharmaceutical processes
- Coordinate validation activities with cross-functional teams including IT Quality Assurance and Manufacturing
- Create and review validation documentation including validation plans protocols and reports
- Ensure compliance with FDA EMA and other relevant regulatory requirements
- Conduct risk assessments and gap analyses for IT systems and processes
- Manage validation projects timelines and resources efficiently
- Collaborate with vendors and internal stakeholders to resolve validation-related issues
- Stay up-to-date with industry trends and regulatory changes in IT validation and pharmaceutical compliance
- Provide training and guidance to team members on validation procedures and best practices
- Participate in audits and inspections related to IT systems and validation processes
Qualifications :
- Bachelors degree in Computer Science Information Technology or a related field
- 3-5 years of experience in IT validation within the pharmaceutical industry
- Strong knowledge of IT validation methodologies and practices
- Proficiency in computer systems validation (CSV) and related documentation
- Familiarity with pharmaceutical industry regulations including FDA and EMA guidelines
- Understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)
- Excellent project management skills with the ability to manage multiple projects simultaneously
- Strong analytical and problem-solving skills
- Proficiency in Microsoft Office Suite and validation documentation tools
- Excellent written and verbal communication skills
- Ability to work effectively in a team environment and collaborate with cross-functional groups
- Detail-oriented with a strong focus on accuracy and quality
- Certifications in IT validation or pharmaceutical quality assurance (preferred)
- Experience coordinating validation activities for software systems and equipment in a pharmaceutical setting
- Knowledge of IT systems used in pharmaceutical manufacturing and research
Additional Information :
At Fusion we aspire to be one of the worlds leading life sciences consulting firms setting industry benchmarks with innovative and pioneering solutions.
At Fusion we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.
Hiring Philosophy: We value employees who push boundaries through innovation navigating diverse client needs in ever-evolving environments with a commitment to continuous learning both for themselves and their colleagues.
Growth & Development: Go beyond grow beyond and maximize impact. Each employee shapes their own journey and our mission is to ignite the spark of greatness while pushing the boundaries of what you are capable of. We cultivate an environment where every individual can thrive and flourish through meaningful connections extended learning motivation and support to experiment with new and innovative approaches including taking risks.
Feedback Culture: We emphasize and promote continuous real-time feedback across all levels. We see feedback as providing individuals with the information and tools they need to develop their strengths and overcome challenges. Feedback is a gift and inspiring individuals is our competitive advantage!
Shape you own journey - How far will you take yourself
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Computer Hardware
- IT Experience
- Mac Os
- Avaya
- Mobile Devices
- Windows
- Help Desk
- IT Support
- Order Fulfillment
- Project Coordination
- Google Suite
- Troubleshooting
About Company
Swiss Delivery Excellence: Transforming Life Science Consulting Worldwide.Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.With over 450 em ... View more
