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Job description
| Protocol Development & Method Validation Design and review analytical protocols for pharmaceutical products. Validate methods in accordance with ICH, USP, EP, and other regulatory guidelines. Regulatory Compliance Validation Ensure adherence to global regulatory standards for analytical methods. Conduct compliance checks and maintain documentation for audits. Method Optimization & Logic Development Develop optimization logic for analytical methods to improve efficiency and accuracy. Implement risk-based approaches for method selection and validation. Technical Leadership Act as a domain expert for cross-functional teams in R&D and Quality Assurance. Provide guidance on regulatory submissions and technical dossiers. Knowledge Management Maintain up-to-date knowledge of pharmacopeial standards and regulatory changes. Train teams on best practices for compliance and method development. ________________________________________ Required Skills & Qualifications Strong expertise in protocol generation, method validation, and regulatory compliance. In-depth knowledge of USP, EP, ICH guidelines, and global pharmacopeial standards. Experience in method optimization logic and analytical risk assessment. Excellent documentation and audit readiness skills.Strong communication and stakeholder management abilities. ________________________________________ Preferred Qualifications Hands-on experience with regulatory submissions and compliance audits. Familiarity with automation tools for method validation and optimization. Advanced degree in Pharmaceutical Sciences, Analytical Chemistry, or related field. |
Qualification
Protocol Development & Method Validation Design and review analytical protocols for pharmaceutical products. Validate methods in accordance with ICH, USP, EP, and other regulatory guidelines. Regulatory Compliance Validation Ensure adherence to global regulatory standards for analytical methods. Conduct compliance checks and maintain documentation for audits. Method Optimization & Logic Development Develop optimization logic for analytical methods to improve efficiency and accuracy. Implement risk-based approaches for method selection and validation. Technical Leadership Act as a domain expert for cross-functional teams in R&D and Quality Assurance. Provide guidance on regulatory submissions and technical dossiers. Knowledge Management Maintain up-to-date knowledge of pharmacopeial standards and regulatory changes. Train teams on best practices for compliance and method development. ________________________________________ Required Skills & Qualifications Strong expertise in protocol generation, method validation, and regulatory compliance. In-depth knowledge of USP, EP, ICH guidelines, and global pharmacopeial standards. Experience in method optimization logic and analytical risk assessment. Excellent documentation and audit readiness skills.Strong communication and stakeholder management abilities. ________________________________________ Preferred Qualifications Hands-on experience with regulatory submissions and compliance audits. Familiarity with automation tools for method validation and optimization. Advanced degree in Pharmaceutical Sciences, Analytical Chemistry, or related field.
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About Virtusa
Teamwork, quality of life, professional and personal development: values that Virtusa is proud to embody. When you join us, you join a team of 27,000 people globally that cares about your growth — one that seeks to provide you with exciting projects, opportunities and work with state of the art technologies throughout your career with us.
Great minds, great potential: it all comes together at Virtusa. We value collaboration and the team environment of our company, and seek to provide great minds with a dynamic place to nurture new ideas and foster excellence.
Virtusa is an Equal Opportunity Employer. All applicants will receive fair and impartial treatment without regard to race, color, religion, sex, national origin, ancestry, age, legally protected physical or mental disability, protected veteran status, status in the U.S. uniformed services, sexual orientation, gender identity or expression, marital status, genetic information or on any other basis which is protected under applicable federal, state or local law.
Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government-issued ID during each interview. All candidates must be authorized to work in the USA.
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