Quality Systems Specialist
4 days ago
As a Senior Quality Associate, you will play a pivotal role in ensuring the continued compliance of our medical device/pharmaceutical Quality Management System with regulatory requirements.
This on-site opportunity allows you to work closely with a professional and committed team, reporting directly to the Head of Quality.
The role involves developing and implementing quality systems, including writing, reviewing, and approving procedures and work instructions. Additionally, you will review and approve change proposals and related documentation for compliance with GMP requirements.
You will conduct Product Quality Reviews and investigate non-conformances, CAPAs, deviations, and complaints. You will also assist with audit findings and audit management, as well as cross-functional support of design and manufacturing.
Routine QA duties include issue and review of batch documentation, incoming and finished goods release. Furthermore, you will plan and execute assigned process improvement projects.
Required Skills and Qualifications- University degree in Science or Engineering, or equivalent.
- At least four years' experience in GMP within Pharmaceuticals, Medical Devices, or a related field.
- Two years' experience in a QA role.
- High level of verbal and written communication, numeracy skills, and thorough knowledge of standards and governing bodies.
- Excellent problem-solving skills and attention to detail.
- Ability to work collaboratively as part of a team.
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