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About the role
- Manager, Quality Assurance Auditor leading compliance audits at Fresenius Kabi. Responsible for domestic and international quality audits and compliance risk identification.
Responsibilities
- responsible for scheduling and leading domestic and international quality audits
- Identifies top compliance risks and communicates to Fresenius Kabi Management
- lead internal audits of Fresenius Kabi facilities based on the FDA’s System Based Inspection Policy and GMP
- develop audit plans, conduct quality audits, prepare audit reports, and communicate findings
- Lead / participate in Global / Divisional internal audits of Fresenius Kabi facilities
- review and evaluate internal audit response against Fresenius Kabi’s policies and procedures requirements
- drive closure of corrective and preventive actions
- follow up on prior audit recommendations to ensure implementation and compliance
- assist in maintenance of the annual external audit schedules
- lead and / or assist with the development of compliance and quality training
- revise, review, and write SOPs, checklists, and quality documents
Requirements
- Bachelor’s degree in sciences (Masters or higher preferred)
- minimum of 8 years of progressive, challenging QA/QC experience in pharmaceutical or biotechnology industries preferred
- Certificate as a CQA Auditor, CQE, etc. is preferred
- minimum 8 years of extensive experience in pharmaceutical and / or biotechnology quality audits including both external and internal auditing
- at least eight (8)+ years of FDA system-based inspection is required
- in-depth knowledge of GMP, sterile drug product manufacturing using aseptic processing or terminal sterilization, and/or API manufacturing
- in-depth understanding of FDA trends, FDA and EU regulations and guidelines, and ISO 9001 standard
- advanced ability to evaluate and apply compliance requirements and guidelines to applicable situations
- experience in leading teams, work as a team, and handle project management activities without supervision
- must be flexible and able to travel domestically up to 50% of the time, with limited international travels
- demonstrates effective time management skills and the ability to adjust to and manage multiple tasks with changing priorities / assignments
- must demonstrate effective communication skills and technical writing ability
Benefits
- comprehensive and thoughtfully crafted benefits and programs
- 401(k) plan with company contributions
- paid vacation
- holiday and personal days
- employee assistance program
- health benefits including medical, prescription drug, dental and vision coverage
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