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Details
Quality Operations Senior Specialist (LOA008170)
Reference: | A008170 | Location: |
Dublin |
Qualification: | Degree | Experience: | 4-5 Years |
Job Type: | Temporary Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
The Role
This Pharmaceutical company is looking to recruit aQuality Operations Senior Specialist, Drug Product, EMEA and Asia Pacificon a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.
Key Duties and Responsibilities:
- Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
- Actively support the Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
- Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT 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 such as Global Regulatory/CMC and the 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 (MLTs) relating to Third Parties.
- Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
- 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.
Qualifications,Knowledge and Skills Required:
- In depth knowledge of cGMP regulations pertinent to the USA, EU and other 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.
- 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 firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
- Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
- Direct experience in interfacing with external manufacturers
Why you should apply
- You will help patients in their fight against serious diseases
- You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
- You’ll get a competitive salary and a great benefits package
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2020 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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