- Review of Manufacturing/Packaging batch records and Quality Control records prior to recommending release of batch.
- Review and approve standard operating procedures (SOPs) and master batch records.
- Review deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented.
- Assist with periodic audits and reviews of contract manufacturers to ensure compliance with cGMPs and other regulatory requirements.
- Assist with the oversight of the supply chain, manufacture and packaging of products in various Contract Manufacturing Organizations.
- Assist with regulatory inspections.
- Artwork Approval
- Support the following activities, as appropriate:
- Processing external 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
- 2+ years' experience in a cGMP regulated manufacturing and packaging environment, with exhibited knowledge or proficiency in Quality Assurance and Compliance.
- Ability to speak, present data, and defend approaches in front of audiences and inspectors.
- 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.
- Understanding and familiarity with FDA & European regulatory requirements, guidelines, and expectations
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
Fastnet - The Talent Group
'Not Just Placers.........Partners'
The Life Science Specialists