This is what you will do:
The QA Specialist (12 months fixed term) for the Bulk Drug Substance (BDS) and Drug Product (DP) facility at AAMF will be responsible for delivering quality assurance activities at the Athlone facility, ensuring that commercial and/or clinical products are manufactured in accordance with cGMP, corporate, and regulatory requirements. This role will oversee quality activities related to the manufacturing and disposition of medicinal products at AAMF. The specialist is responsible for ensuring that manufacturing, testing, labeling, and storage of products comply with all applicable regulations. This includes oversight of the AAMF QMS to ensure compliance with quality and regulatory standards in line with business needs.
The QA Specialist executes site QA activities at Alexion Athlone to protect product safety, quality, and efficacy, ensuring the availability of safe products for patients and safeguarding the company's business and global markets. The role requires effective interaction with other departments and locations regarding GMP document review and approval, partnering with stakeholders such as Operations, QC, Technical Services, and Engineering to optimize patient supply.
You will be responsible for:
1. Providing quality and cGMP input and oversight for all manufacturing activities at the Bulk Drug Substance facility.
2. Reviewing and approving technical support documentation (e.g., cleaning, process, method validation).
3. Reviewing and approving functional area documentation (e.g., SOPs, work instructions, technical reports, protocols).
4. Participating in quality risk assessments and providing oversight to ensure effective maintenance and control of risks.
5. Reviewing and approving validation protocols as required.
6. Supporting inspection readiness activities, including interactions with inspectors and responses to inspection observations.
7. Reviewing and approving Master Batch Records in accordance with internal procedures and GMP principles.
8. Overseeing quality management system activities such as deviations, CAPA management, change control, and preventive maintenance.
9. Providing oversight of calibration and preventative maintenance criticality assessments.
10. Authoring, reviewing, and approving quality-related procedures.
11. Supporting vendor/supplier management and raw material qualification programs.
12. Developing and reporting quality metrics.
13. Ensuring effective documentation and tracking of quality management activities.
14. Performing day-to-day tasks and supporting projects for continuous improvement.
You will need to have:
1. B.Sc. in Science or Engineering with a minimum of 3 years’ experience in a cGMP quality environment, or an equivalent combination of education and experience.
2. Minimum 3 years’ experience in a QA environment within the pharmaceutical industry or related field.
3. Strong knowledge of cGMP requirements for pharmaceutical manufacturing.
4. Direct experience with GMP management in a pharma/biopharma setting, including exposure to FDA, HPRA, or similar authorities.
5. Excellent accuracy and attention to detail.
6. Good knowledge of relevant computer packages (e.g., Trackwise).
7. Strong planning and organizational skills to manage commitments and adapt to changing priorities.
8. Excellent interpersonal and communication skills, both verbal and written.
9. Proven ability to multi-task and manage time effectively.
Preferred qualifications:
1. Experience in sterility assurance for drug substances and products, and manufacturing processes for pharmaceutical products.
2. High-level technical skills including auditing, pharmaceutical manufacturing, and regulatory inspection management.
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