Quality Operations Manager
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Sector:
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Job type:
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Contact:
Gillian Dunphy
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Contact email:
gillian.dunphy@nextgeneration.ie
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Contact phone:
353 (0)1 960 9773
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Job ref:
21-11722
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Published:
almost 3 years ago
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Expiry date:
2021-07-08
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Startdate:
2021-06-28
Quality Operations Manager
Could this Quality Operations Manager role be your next dream job? Do you have experience managing quality operations in a Pharmaceutical environment? If you are interested in a fantastic opportunity working at an amazing company then keep reading!
This is a one-of-a-kind job in a well-established Biopharma company. | Are you looking to grow your career? Look no further, this is the job for you!
Their team is growing and they need someone like you to join them and continue to drive quality operations.
This is a permanent full-time job based in Dublin.
What will you do in this job?
- Support the co-ordination of quality events, change control and market complaints programs in respect of third-party manufacturers
- Provide quality/compliance support to the wider supplier relationship management, global procurement, supply chain teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
- Provide the requisite quality support to global functional groups and local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
- Coordinate quality metrics programs in relation to third party performance.
- Provide support to quality operations management team in technical transfer projects and manufacturing launch teams relating to third parties.
- Assist in the preparation of quality agreements with the third-party manufacturers
- Review the annual product reviews submitted by the third-party manufacturers.
- Support the global external auditing program by participation in audits of third parties as requested.
- Provide support to specified quality and technical projects as they arise.
What do you need to be successful in this job?
- A BSc in a Scientific discipline such as Chemistry or Microbiology
- Minimum 5 years' experience in the pharmaceutical industry, preferably in quality, manufacturing technology, regulatory or a position within a Health Authority Agency
- Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables first-hand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
- In depth knowledge of cGMP regulations pertinent to international markets
- Ability to develop cross-functional and external working relationships
- Strong communication and presentation skills across all levels both internal and external
- Proven analytical and problem-solving skills.
- Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
- Direct experience in interfacing with external manufacturers
What's in it for you?
- A competitive salary with incentives/bonus.
And… much more!
The Next Step for you:
Interested in this role? Please send your CV to GILLIAN DUNPHY at Next Generation Recruitment by clicking on the Apply button!
Not ready to apply just yet? Meet with our recruiters here or get some inspiration to update your CV there.
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