Quality Assurance Professional
2 weeks ago
Quality Assurance Expertise
">We are seeking an expert to join our team in developing and implementing site quality systems. The successful candidate will play a key role in ensuring the manufacture and release of Combination products meet rigorous standards.
The Role & Responsibilities- Develop and implement site Quality Systems, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review.
- Provide QA support to ensure Inspection Readiness.
- Collaborate with stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.
- Support operation of the site Training system.
- Ensure Regulatory Compliance.
- Educated to degree level with industry experience.
- Working knowledge of EU & US regulatory requirements.
- Experience in designing and implementing quality systems is advantageous.
- Knowledge of inhalation dosage forms is advantageous.
- High proficiency in Microsoft Office applications.
- Proficiency in electronic systems/databases.
- Strong communication and team working skills.
- Ability to work flexibly in a changing environment.
Competitive salaries and benefits package.
Inclusive work environment.
Opportunity for career progression and work-life balance initiatives.
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