Description
We are seeking an experienced Quality professional to serve in a consultant role reviewing CQV documentation in support of a new sterile fill/finish production line at one of our anchor accounts. The ideal candidate will bring strong knowledge of cGMP principles, validation lifecycle requirements, and documentation standards within regulated environments. This role will not involve authoring or executing validation protocols, but rather reviewing documentation for compliance, completeness, and alignment with applicable regulatory and internal standards.
Key Responsibilities:
- Review Commissioning, Qualification, and Validation (CQV) documentation (e.g., protocols, summary reports, risk assessments) for equipment, facilities, utilities, cleaning, and computerized systems associated with a sterile fill/finish production line.
- Ensure reviewed documentation complies with applicable regulatory expectations (e.g., FDA, EU Annex 15, ICH Q8–Q10) and internal procedures.
- Provide feedback and recommendations to project teams on documentation content, structure, and alignment with industry best practices.
- Collaborate cross-functionally with client Engineering, Validation, Quality, and Project Management teams to advise on quality expectations and CQV documentation readiness.
- Utilize client systems including Veeva Vault, TrackWise, and Maximo to support document review, change control, and issue tracking activities.
- Support resolution of quality comments or issues related to validation documentation through advisory input and collaborative problem-solving
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related field.
- 8+ years of experience in validation or quality roles in the pharmaceutical or biotechnology industry.
- Strong knowledge of validation documentation lifecycle, cGMPs, and regulatory guidance related to equipment, facilities, and computerized systems.
- Experience reviewing CQV documentation in sterile or aseptic manufacturing environments.
- Familiarity with Quality Management Systems such as Veeva Vault, TrackWise, and Maximo.
- Excellent attention to detail, written communication skills, and ability to provide constructive quality input
Preferred Qualifications:
- Prior consulting or advisory experience.
- Experience supporting large-scale capital projects or greenfield facility startups.
- Understanding of barrier technology, aseptic process validation, or automated fill/finish equipment.
Salary Range: 110k-125k
Benefits
- Health Care Plan (Medical, Dental & Vision)
- Retirement Plan (401k)
- Life Insurance (Basic, Voluntary & AD&D)
- Paid Time Off (Vacation, Sick & Public Holidays)
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.
