Opportunity to work as a QA CMO with a leading Biopharma company
This person is to provide QA support for external contract manufacturing operations.
The successful individual needs to have:
- 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.
- 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.
What you will do:
- 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
- Minimum requirement is a Level 7 in a technical discipline (physical, engineering, chemical or biological sciences) is required.
This is a 23 month contract role with the opportunity to extend.
If you would like to learn more about the role contact Kellie O' Donovan on 021 2300 300 or firstname.lastname@example.org
Morgan McKinley is acting as an Employment Business in relation to this vacancy.
Please note that any references to salary or pay rates in this advertisement and in the salary refinement section are indicative only and should only be used as a guide.