AX-7201 Quality Systems Co-ordinator
This broad position at a Global specialty-driven biotech company will have responsibility for providing full QA systems support to the in-house team responsible for supporting external manufacturing organisations globally.
Global specialty-driven biotechnology group
Offer products in oncology and endocrinology amongst others
Launches anticipated over the next 2 years
Excellent potential for career development within the QA group
Flat structure with every role in the QA group offering high exposure to company senior leadership team
Responsible for the provision of QA support to the EMO team for all Drug manufacturing and testing activities performed at Contract Manufacturing Organisations (CMOs) and Contract Testing Laboratories (CTLs).
Provide direct support to the Director of Quality in the management of the day today aspects of the QA Department, including deviation close out and associated investigations, supporting the Product Quality Review and Change Control processes and participating in quality-based projects.
Day to day use of Trackwise and Documentum, implementing new processes and driving continuous improvement
Provide QA Support and maintenance of Quality systems, metrics and documentation.
Provide support on product manufacturing and testing to Third-Parties and to the Technical, Regulatory CMC functions within the company’s External Manufacturing Organisation.
QUALIFICATIONS / EXPERIENCE REQUIRED:
- MSc in a Life Sciences discipline ideally in Pharmacy Chemistry, Microbiology or Engineering
- Previous experience in a QA environment within a pharmaceutical company or CRO
- Understanding and experience of: Pharmaceutical Quality Regulations, Quality Management System Implementation and Risk Analysis
- Experience in manufacturing and testing technology transfer involving CMOs/CTLs.
- Ability to build strong collaborative relationships with SMEs at CMOs/CTLs.
- Ideally experience of ‘other’ industry quality systems/standards, e.g. ICHQ10, ISO 9000. Experienced GxP Auditor, Experience in process Improvement. Experience of working with / in a CMO.
For a confidential discussion please telephone Sukhveer Gill at AXESS Limited on 020 8560 2300.
To apply, please click the APPLY ONLINE button.
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AXESS has been operating since 1990
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