Spécialiste validation

☞ Clinigen Clinical Supplies Management

看过: 135

更新日: 16-11-2025

位置: Mont-Saint-Guibert Walloon Brabant

类别: 其他

行业:

工作类型: Full-time

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工作内容

QA Validation Specialist

ORGANISATION
Clinigen Group plc is a rapidly-growing global specialty pharmaceutical and services company with a unique combination of businesses focused on delivering the right medicine to the right patient at the right time to improve the quality of people’s lives around the world. The group consists of complementary businesses that focus on key areas of global medicine supply: clinical trial, unlicensed and licensed medicines. Our businesses can operate efficiently in a complex global regulatory environment and can ensure that precious medicines are delivered securely and effectively, wherever they are needed throughout the product lifecycle.

We are currently 1000+ people, headquartered in the UK, with sites in Burton-on-Trent, Weybridge and global offices in the US, Asia Pacific, South Africa, and across Europe. Clinigen is a rapidly growing company that has a great future ahead. To sustain our growth, we’re always on the lookout for motivated, ambitious and committed individuals to join our highly successful team.

ROLE
In the framework of the compliance project, the QA Validation Specialist will:
- Put in place an active SVMP and keep it live and up to date
- Ensure we have a validation system, sops and templates to enable us to perform continuous process verification
- Meet the ever increasing validation requirements of audits and inspectors for Clinigen CSM
- Use risk-based approaches to make validation activities efficient, cost-effective and defendable
- Take the lead for validation activities from a Quality Perspective
- Validation Master Planning
- Retrospective review of validation activities in order to prioritise and define future work
- Writing a site validation master plan and annual assessment
- Risk-based approach to validation activities
- Be able to lead a validation/qualification
- Take the lead for validation activities from a Quality Perspective
- Data Integrity risk assessment and principles

REQUIREMENTS
- Experience in Quality Assurance (1- 3 years)
- Experienced in wide range of validation activities-facility qualification, equipment qualification, process validation, cleaning validation/verification
- Experience in data integrity and computer system validation
- Experienced in GMP, GDP, and GCP requirements
- Experience in working in a matrix organization

Skills
- Excellent communication and intercultural skills
- Team worker and team spirit
- Customer oriented
- High organizational and planning skills
- Work with accuracy and reliability
- Good dose of assertiveness
- Good computer skills: MS office, other office software
- Fluent in French and English
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最后期限: 31-12-2025

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