Department: Azzur Labs, LLC
A) Performing Tests: This will be 80%
- Develop auditing process and documents for assessment of Azzur Labs sites.
- .Responsible for conducting GMP Audits of Azzur Labs sites, including, but not limited to, planning the events, leading and conducting, documenting and following up, and reporting audits.
- Provide regulatory guidance of compliance across all quality management systems.
- Responsible for review of corrective actions planned or implemented as a result of audit findings.
- Assist Global Quality Director in the review of procedures compliance with regulatory requirements.
- Assist with/act as SME for regulatory/ISO audits of Azzur Labs.
- Collaborate with the quality department at the Azzur Labs site to ensure appropriate GMP training is provided.
- Attends professional seminars and correspondence with others in similar Quality Assurance positions where possible.
- Coordinate with Global Quality Director for scheduling of audits of Azzur Labs sites and content requested for individual audits.
- Collaborates with the schedule of Azzur Labs facilities to conduct reviews/audits where determined to be necessary.
- Support the strategic development of an effective global risk-based audit strategy.
Required Work Experience:
- 10 years experience or 9 years experience with a Master’s degree
- 5 years of experience in the Pharmaceutical industry.
- Related or equivalent experience may be substituted.
- Extensive FDA GMP regulatory knowledge
- Knowledge of qualities activities.
Fulltime Employment with Azzur can offer you:
- Flexible PTO
- Training and Development Opportunities
- 401(k) match
- Bonus Eligibility
- Medical Benefits
- Paid Holidays
- Company provided laptop
Who we are:
Azzur Group is dedicated to providing clients with efficient, innovative quality and compliance solutions from Discovery to Delivery™. With more than 500 industry partners, including 80% of the top pharma/biotech manufacturers in the U.S., Azzur Group provides carefully calibrated and efficiently executed project management, process engineering, and compliance services. As one of the fastest-growing private companies in America, Azzur Group provides clients with consulting, facility solutions, engineering, validation, IT, technical, training, COD, laboratory services, and solutions they need to remain innovative and competitive.
Azzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.#LI-PK