QA Specialist, BDS (12 month fixed term contract)

AstraZeneca; Athlone; On-site; EUR 45,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in Athlone is seeking a QA Specialist to ensure compliance and oversee quality activities in manufacturing. You will work closely with various departments, emphasizing cGMP standards. The role requires a B.Sc. in Science/Engineering and a minimum of 3 years in a QA environment. If you're passionate about improving quality and compliance, apply now!

Qualifications

• Minimum 3 years’ experience in a QA environment within the pharma industry.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing.
• Direct experience with regulatory authorities like FDA or HPRA.

Responsibilities

• Provide quality and cGMP input for all manufacturing activities.
• Review and approve technical support documentation and SOPs.
• Participate in quality risk assessments.

Skills

Quality oversight

cGMP knowledge

Attention to detail

Interpersonal skills

Planning and organizing skills

Education

B.Sc. in Science/Engineering

Tools

Trackwise

Job description

Are you ready to make a difference in the world of pharmaceuticals? As a QA Specialist at the Bulk Drug Substance (BDS) facility in Athlone, you'll play a crucial role in ensuring the quality and compliance of our products. Your expertise will be vital in overseeing quality activities related to the manufacturing and disposition of bulk drug substances, ensuring they meet cGMP, Corporate, and Regulatory standards. You'll collaborate with key stakeholders across departments to optimize patient supply and safeguard the safety, quality, and efficacy of our products. Are you up for the challenge?

Accountabilities

• Provide quality and cGMP input and oversight for all manufacturing activities for the Bulk Drug Substance facility.
• Review and approval of technical support documentation. (Examples include cleaning, process, method validation).
• Review and approval of functional area documentation (e.g. SOPs, Work Instructions, technical reports and protocols)
• Participate in quality risk assessments and provide quality oversight to ensure quality risk assessments are effectively maintained/controlled.
• Review and approve Validation protocols as required.
• Provide support and expertise for inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, to monitor progress of follow-up actions.
• Responsible for review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
• Provide oversight of quality management system activities including Preventive Maintenance, Deviation and CAPA Management and Change Control Programs.
• Provide quality oversight of calibration and preventative maintenance criticality assessments as required.
• Author, review and approve Quality Related Procedures as required.
• Support the Vendor/Supplier Management Program.
• Support the Raw Material Qualification Program.
• Develop and report quality metrics
• Oversee the effective documentation and tracking of quality management system activities including deviations, change control and CAPAs.
• Review and approve Validation protocols as required.
• Perform day-to-day tasks, as well as assist with projects that support company objectives and continuous improvement initiatives.

Essential Skills/Experience

• B.Sc. in Science/Engineering with a minimum of 3 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
• Minimum 3 years’ experience in a QA environment within the pharma industry or a related field.
• Strong knowledge of cGMP requirements for pharmaceutical manufacturing required.
• Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing.
• Excellent accuracy and attention to detail.
• Good knowledge of relevant computer packages e.g. Trackwise or similar.
• Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
• Excellent time management organizational skills along with a proven ability to multi-task.

Desirable Skills/Experience

• Experience of sterility assurance for drug substance and/or drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
• High level technical skills including auditing, pharmaceutical manufacturing and regulatory inspection management.

At AstraZeneca, we are driven by a passion for innovation that transforms lives. Our culture is built on diversity, inclusion, and a commitment to making a meaningful impact. We empower our employees with opportunities for growth and development while fostering an environment where new ideas thrive. Join us in our mission to change lives for the better through groundbreaking science and compassionate care.

Ready to take the next step in your career? Apply now to join our team!

Date Posted 27-Nov-2025

Closing Date 10-Dec-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.