- Assist with the oversight of the supply chain, manufacture and packaging of products in various Contact Manufacturing Organizations.
- Review of Manufacturing/Packaging batch records and Quality Control documentation prior to recommending batch release.
- Review and approve standard operating procedures, master batch records and product specifications.
- Provide Quality oversight of deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Proactively support the continuous improvement of quality systems by identifying and building in efficiencies from a systematic and compliance perspective.
- Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
- Assist with regulatory inspections.
- Artwork Approval
- Support the following activities, as appropriate:
- Processing external customer complaints
- Quality Deviations and Laboratory Investigations
- Change Controls
- New or updates to relevant quality agreements
- Validation activities
- Perform Audits internal & external
- Annual Product Reviews
- Recalls and/or notification of events to regulatory agencies
- A minimum of 5 years' experience in a cGMP regulated drug substance, drug product manufacturing and/or packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Bachelor of Sciences (BSc) degree, or higher, in a technical discipline (physical, engineering, chemical or biological sciences) is required.
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
- Experience with participation in regulatory inspections presenting or defending departmental functions in audits or regulatory inspections.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations.
- Excellent interpersonal skills with the ability to work as part of a dynamic team and efficiently engage both interdepartmentally and with external CMO's.
Note: This description is not intended to be all-inclusive or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned
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