Validation IQ/ OQ/ PQ protocol generation, execution, and report writing with experience in the following:
Installation & Qualification Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, Requirements Traceable Matrix (RTM), URS, FRS, IQ, OQ, RQ, PQ Protocols, SOP's/Work instructions, System problem reports, System Certification Summary/Compliance Report, Release statements and Release memo, VSR.
Development of validation master plan (VMP) and standard operating procedures (SOP).
Updating and maintenance of Requirement Traceability Matrix (RTM), performance of Gap Analysis and development of Remediation Plans.
Calibration, commissioning, qualification (IQ, OQ, PQ), decommissioning of units, along with execution and documentation and writing final reports.
Understanding of automated process control systems, clean room and classified area requirements for Aseptic Environment.
Responsible for the resolution of deviations, CAPA’s, root cause analysis techniques during deviation investigational process.
Working in a strictly regulated cGXP environment for all the aspects of equipment Validation and maintained electronic records in compliance with 21 CFR Part 11.
• Validation Skills: 21CFR part11, Part 210/211, 820, 58, GMP, GCP, GLP, GDP Rules, ICH Q8 and Q9, ISO 13485, GAMP.
Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.
Do What You Love
At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.
Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!