Posted: 31 July
Offer description
Quality Assurance Professional
We are seeking a highly motivated Quality Assurance Professional to fill this key role. As a member of our quality team, you will play a critical role in ensuring the quality of our products and services.
* Develop and implement site quality systems to support the manufacture and release of Combination products, 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 site to ensure Inspection Readiness.
* Collaborate with key stakeholders including Engineering, Validation, Manufacturing, Regulatory and Global Quality.
* Support operation of the site Training system, including preparing and presenting relevant training material, as required.
* Regulatory Compliance; support Dublin Respiratory reviews and generation of supporting documents including API Declaration, Approved Product List, Approved Oversight List.
* Keep abreast of regulatory initiatives and new guidance/requirements.
About Your Skills & Experience:
* Educated to degree level with proven industry experience.
* Working knowledge of EU & US regulatory requirements.
* Experience in designing and implementing quality systems and/or a start-up an advantage.
* Experience in or knowledge of inhalation dosage forms an advantage.
Why This Role?
* Competitive salaries and benefits.
* Inclusive environment where you can use your experiences, perspectives and skills to make an impact.
* Excellent career progression opportunities and work-life balance initiatives.
