Department: Azzur of NE, LLC
Essential Duties and Responsibilities
- Generate, review and approve validation and compliance documents supporting GxP computerized systems, and relevant infrastructure, including those related to system procurement, audit, performance, compliance evaluation, and validation.
- Provide support for SOPs, qualification protocols, gap assessments, risk assessment, Impact Assessment, user requirements, functional and configuration specifications, requirements traceability, validation plans, validation summary reports and change controls.
- Execute protocol execution, documentation of results, deviations, and corrective actions, and preparation of Summary Reports, Trace Matrices and Summary Reports associated with validated computer systems
- Perform Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
- Ensure regulations, such as 21 CFR Part 11, 820 and cGMP, are addressed in validation.
- Performs periodic reviews and ongoing support of validated systems post Go-Live.
- Perform revalidation and change control validation related activities.
- Assess the impact of system changes through change management and change control systems; participate in the planning and implementation of change.
- Provide training to colleagues and contractors on systems implementation and validation SOPs.
- Assist validation activities of cross-functional teams that include technical functions such as Information Systems, Manufacturing and QA Engineering.
- Develop and maintain Validation SOPs, forms, documentation and files.
- Five plus (5+) years of relevant CSV, validation, automation, and engineering experience within a cGMP environment
- Computer systems experience with manufacturing, equipment and process, as well as utilities, and facilities qualification.
- Experience in Labeling/Packaging System Validation is preferred.
- Experience in the biotechnology and/medical or pharmaceutical industry required.
- Proficiency of Computers Systems Validation and Quality Systems.
- GMP compliance knowledge including knowledge of 21 CFR Parts 11, 210, 211, and 820 requirements, Data Integrity, ICH Q7A requirements, and GAMP
- Experience in thorough testing of applications, computerized systems, changes and implementation
- Experience with Veeva platform and applications a plus
- Excellent written and verbal communication
- Ability to work in a fast-paced environment.
- Team oriented with independent work skills and a strong work ethic.
- Microsoft Office and database management skills.
Who we are:
Azzur Group is a professional service company providing biotechnology and pharmaceutical clients with engineering, validation, CSV-IT, technical, and consulting services. At Azzur, we look to hire full-time consultants who deliver results to our valued clients while providing you the opportunity to develop and grow in the industry through diverse project assignments. Using our 4 Core Values as guidance, we expect all Azzur Employees to:
- Put Others First,
- Have the Courage to Take Action,
- Take Personal Responsibility, and
- Have Fun!
Azzur can offer you:
- Flexible PTO Policy
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
If you can deliver high-quality customer service and results while engaging in our fun and energetic culture; we want to hear from you!