Description:
As Quality Specialist, you will play a pivotal role in the development of this facility.
Your main responsibilities will include:
- Quality oversight, with Management support, of on-site manufacturing operations, internal materials management, warehousing operations, and quality control testing activities
- Quality oversight, with Management support of operational activities which occur at approved outsourced service providers (QC testing, material storage, material supply, cleanroom etc)
- Preparation and review of Quality Agreements
- Supplier GxP monitoring during onboarding and throughout lifecycle
- Perform batch documentation review, QA SME for key Quality systems including change control, complaints, deviations, validation, quality risk management and product annual reviews related to manufacturing operations and GxP processes
- QA SME for Quality Risk Management activities
- Support the QA leadership and QP team in relation to preparation and review of the relevant documentation for release activities
- Responsible for quality review and approval of Master Batch Records in accordance with our internal procedures and GMP principles.
Education & Experience:
- At least 3 -5 years’ experience in cGMP Pharmaceutical Operations is essential including direct experience with Quality systems
- Primary Degree in scientific discipline or equivalent
- Ability to work independently and flexibility within a start-up organization and to influence a high-performance Quality culture