We are seeking a highly experienced Senior Specialist in Quality Engineering with a solid background in Computer System Validation for our Bangalore team. This role is critical for ensuring the quality and compliance of our life sciences applications through robust testing and validation processes.
- Lead and execute Computer System Validation (CSV) activities for life sciences applications, ensuring adherence to regulatory standards.
- Oversee Quality Assurance Software Testing activities, from planning to execution and reporting.
- Develop and optimize IT processes to ensure compliance with relevant regulations and industry standards, including GxP and 21 CFR Part 11.
- Manage the end-to-end validation process, including the creation of Validation Plans, Reports, and Installation Qualification baselines.
- Collaborate with project and integration management teams to drive quality throughout application development and maintenance projects.
- Track, review, and approve all quality deliverables, ensuring accuracy and completeness.
- Support internal and external audit management activities, providing necessary documentation and expertise.
- Contribute to the setup and maintenance of Quality Management Systems (QMS), including process definition and SOP creation.
- Apply expertise in GAMP5 guidelines and other relevant industry best practices to all validation efforts.
- Ensure good documentation practices are consistently followed across all quality and validation activities.
Skills and Qualifications
Mandatory: Proven expertise in Computer System Validation (CSV) - Testing.
Extensive experience in Quality Assurance and Software Testing within the life sciences domain.
In-depth knowledge of GxP, 21 CFR Part 11, ICH GDP, ERES, and GAMP5 guidelines.
Experience with QMS setup, process definition, SOP creation, and SQA activities.
Familiarity with ISO 27001:2013 and ISO IEC 27701:2019 (GDPR) principles.
Strong understanding of IT process implementation and optimization for regulatory compliance.
Ability to manage traceability matrices and support audit management.
Excellent communication, presentation, and interpersonal skills.
Demonstrated ability to work in a client-facing role and manage multiple functions simultaneously.
Highly driven, flexible, resourceful, and capable of multitasking with a strong attention to detail.
A proactive approach to problem-solving and a commitment to delivering high-quality outputs within timelines.
Mandatory Skills : Computer System Validation(CSV) - Testing