Vacancy Description
Job Description
- Support Quality Assurance activities related to sterile manufacturing and filling operations.
- Assist with the preparation, assessment and follow-up of change controls.
- Support deviation investigations and ensure that the related documentation is complete and accurate.
- Follow up on actions arising from deviations, change controls and other quality records.
- Review manufacturing and quality documentation for completeness, consistency and GMP compliance.
- Clarify incomplete or unclear documentation with internal stakeholders and the external manufacturing partner.
- Monitor open quality records and support their timely progression and closure.
- Maintain an overview of several ongoing quality topics and communicate outstanding actions.
- Support the evaluation of quality issues within their practical manufacturing context.
- Assist with batch record reviews following the i...
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