Quality Assurance activities include
Audits & Qualifications
- Performance of GMP and GDP audits.
Quality Agreements
- Drafting and review of quality agreement.
Qualification & Validation
- Writing of process validation documents.
- Supervision of tests.
- Troubleshooting and management of non-conformities.
Life Cycle Management
- Life cycle management expertise according to ICH Q12.
- Change management.
- Technical support in case of quality issue.