This is what you will do:
Our QA Specialist plays a key role in ensuring the quality and integrity of our products.
The position oversees commercial and clinical manufacturing operations at the Athlone facility, working closely with cross-functional teams to protect product safety and quality.
You will be responsible for:
* Providing technical expertise on all QA and compliance topics relating to Alexion manufacturing and product supply.
* Serving as quality point person, offering guidance and feedback on quality assurance issues.
* Performing timely reviews of documentation, investigations, and reports to identify and assist in resolving quality-related issues.
* Maintaining schedules for review and approval of GMP documents to support Clinical and Commercial Operations groups.
* Offering sound QA and Compliance support to manufacturing, engineering, utilities, supply chain, and material movement teams for both clinical and commercial products.
* Ensuring relevant QA documents and procedures are approved in advance to support technology transfers and new product introductions.
* Supporting deviation investigations, including root cause analysis, and CAPA proposals and initiatives.
* Delivering Quality Assurance review and approval of SOPs, master batch records, policies, operational standards, validation protocols, and reports as required.
* Contributing to continuous improvement activities.
* Supporting Quality Control activities.
Qualifications:
* A minimum of 3 years relevant experience within the pharmaceutical industry or a related field.
* Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging is required.
* Experience in sterility assurance for drug products/substance and manufacturing processes for pharmaceutical products and processes is desirable.
* Direct experience of GMP management within a pharma/biopharma company, including exposure to FDA, HPRA/EMA, or other similar authorities is essential.
* Excellent accuracy and attention to detail.
* Familiarity with relevant computer packages, such as Trackwise or similar.
* Planning and organizing skills to plan, execute, and track Quality Assurance commitments and adjust to changing priorities.
* High-level technical skills, including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management.
* Technical writing skills.
* Excellent interpersonal and communication skills, both verbal and written.
Education:
* A third-level qualification, such as a B.Sc. in science/pharmacy, with a minimum of 3 years' experience in a cGMP Quality environment; or an equivalent combination of education and experience.
Competencies:
Planning and organizing skills to plan, execute, and track Quality Assurance commitments and adjust to changing priorities.