CSV QA Consultant

Location: Worcester, MA
Department: Azzur Worcester, LLC

Job Description

From Discovery to Delivery™, Azzur Group provides the life science community with full lifecycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to labs, training centers, and consulting and advisory offices across the nation, Azzur helps organizations start, scale, and sustain their enterprises. With four decades of service to the industry, we've become a trusted partner to leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.


Essential Duties and 
Responsibilities

  • Perform Quality review computer system documents and executed activities for validation of computerized systems. Review and provide feedback on CSV protocols, reports and software related documentation.
  • 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.

Requirements

  • 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.

Benefits

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



Do What You Love

At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals.  We take crucial steps to ensure that each employee is fulfilled both in and out of the office.

In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having Fun. 

It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent and fun company culture are something you are looking for in your next role, Azzur is the place for you.

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added projects/results
  • Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry
  • Willing to work hands on, assist with building client libraries, learn from a mentor and become a mentor for others. 
  • Understands worldwide regulations and phase appropriate applications
  • Draws insights from projects and supplemental research to help drive new and existing growth. 
  • Ensures activities are efficient, optimized, and client-centric. 
  • Highly motivated and organized, solutions oriented leader
  • Curious and adaptable - has the ability to transform knowledge into actionable activities
  • Able to produce results in a fast paced, collaborative environment   
Azzur Group is an equal opportunity employer and promotes a diverse culture in our workplace. We believe that promoting diversity plays an important role in developing top-quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 


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