QA Validation Engineer
The QA Validation Specialist will be part of a cross functional team that will develop and execute validation studies for GMP computerized systems. This includes the generation of validation plans, validation protocols, summary reports, and change controls. The QA Validation Specialist will also support validation lifecycle activities and will participate in the review and approval of validation documents.
The development and execution of validation studies requires direct communication with internal and external cross functional teams. Effective communication is essential for alignment on strategies and approaches, and correcting deficiencies while maintaining good working relationships. A thorough understanding of current regulations and guidelines such as 21 CFR Part 11, EudraLex Volume 4, Annex 15, and GAMP 5 is required.
- Generates and / or supports the generation of risk assessments, user requirements specifications (URS), validation plans, change requests, SOPs, and other relevant computer systems validation documents.
- Supports validation lifecycle activities to ensure that computerized systems remain in their validated state.
- Leads data integrity risk assessments efforts for validated systems.
- Leads the validation effort of enterprise systems
- Provides assessments and recommendations related to systems integration needed to preserve the integrity of the data lifecycle.
- Supports the qualification/validation effort driven by the MSAT group.
- Provides support during clients and regulatory audits.
- Other duties as assigned.
- Understanding of current regulations and guidelines (e.g., 21 CFR Part 11, EudraLex Volume 4 - Annex 15, GAMP 5, etc.) and how to apply them to support the validation effort.
- Technical writing skills to effectively develop procedures, discrepancies, change controls and associated documents needed to support the validation effort.
- Experience developing and executing validation activities for computerized systems.
- Understanding of the regulatory expectations for Data Integrity.
- Experience performing data integrity risk assessment is preferable.
- Ability to manage multiple projects, create and work within internal timeliness, solve problems, deliver on commitments, and utilize interpersonal skills in a cross-functional team.
- Understanding of IT systems, services, and infrastructure is preferable.
- Strong time-management skills and the ability to organize and coordinate multiple projects at a time.
- Proficiency in enterprise systems, Microsoft Office, and other office productivity tools, with aptitude to learn new software and systems.
Education and Experience
- Bachelor’s degree in science, Engineering, or related field with 3-5 years of experience in the pharmaceutical industry.
- At least three years of experience performing validations for computerized systems