Senior Quality Assurance Officer
2 weeks ago
About the Role
The Senior QA Officer will play a key role in ensuring the quality and compliance of our products and processes. This includes leading the review and approval of batch production records and quality control testing data, as well as coordinating and approving non-conformances and CAPAs.
Key Responsibilities
- Leading activities that support CGT manufacturing and weighing schedules
- Reviewing and approving batch production records and quality control testing data
- Coordinating and approving non-conformances and CAPAs
- Managing documentation and change control processes
- Providing technical support and training to colleagues
Requirements
- BSc/BA degree in a relevant life science field
- Experience working in a Quality Assurance or Quality Systems function
- Experience working in a cGMP environment
- Knowledge of ISO 9001, ISO 13485, and 21CFR part 820
Personal Qualities and Attributes
- Excellent team working skills
- Ability to critically review documentation
- Methodical and highly organized
- Excellent attention to detail
- Excellent time management skills
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