**Only candidates local to the New England region of the United States will be considered**
Azzur Group is seeking a Computer Systems Validation Lead for our office! The CSV Lead will be responsible for mentoring junior CSV Engineers and building a robust CSV program. An exciting opportunity to lead and create a CSV program!
·Author, and review computer system validation documentation, including validation plans, risks assessments, IQ/OQ, URS/FRS, PQ, test scripts, trace matrix, final summary reports for analytical instrumentation ensuring GxP and data integrity requirements are maintained.
·Review and approve periodic reviews of qualification and computer system validations ensuring compliance with the qualified/validated state of the system(s). Ensure appropriate remediation plans are identified for gaps identified during the periodic reviews.
·Facilitate the schedule with various department leads with the scheduling of PQ testing.
·Execute test scripts associated with administrative activities.
·Assist with developing a program for maintenance and update of laboratory computers to keep pace with evolving standards for computers.
·Facilitate change controls for implementation and retirement of instrument/equipment.
·Prepare documentation and provide support for regulatory inspections and inspection readiness activities.
·Ensure department SOPs adhere with Corporate Policies, Corporate Procedures, and regulatory expectations.
· Ability to take initiative and prioritize objectives from multiple projects; adhere to scheduled timelines while maintaining flexibility.
·Must have knowledge of good documentation practices, GxP, regulatory requirements for computerized analytical systems validation (i.e. 21 CFR part 11) and disaster recovery.
·Interpersonal, oral and written communication skills are essential. Must contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals.
·Working knowledge of various lab based systems and techniques, as well as validation of custom developed software concepts preferred.
Azzur Group provides a wide-range of business-to-business professional services and solutions to clients in the pharmaceutical, biotechnology, and medical device industries. We specialize in manufacturing systems, equipment design/installation & startup, commissioning, verification & qualification, all areas of validation, quality assurance, quality control, compliance & audit support, as well as general project/program management.
At Azzur, our greatest strength comes from our people. We have the ability to hire consultants as full time internal employees, providing security and exceptional growth opportunities. They not only have superior technical skills but also adhere to our core values of Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility, and Having fun. Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and clients.
Our Vision: To be the premier choice of clients and talent across our services and products.
Our Mission: To lead the healthcare and life science industries in innovative quality and compliance solutions from Discovery to DeliveryTM.
Location/Region: Waltham, MA (US)