QA Specialist, 12 month fixed term contract (Extended days)

Are you ready to make a difference in the world of pharmaceuticals? As a QA Specialist at the Bulk Drug Substance (BDS) facility at ADMF, you'll play a crucial role in ensuring the quality and compliance of our products. Your expertise will be vital in overseeing manufacturing, testing, labeling, and storage processes to meet GMP regulations and product authorizations. You'll collaborate with various departments to optimize patient supply and ensure the safety, quality, and efficacy of our products. This shift position operates on extended days, offering a dynamic work schedule that keeps you engaged and challenged.

Accountabilities:

• Provide quality and cGMP input and oversight for all commercial manufacturing in the BDS facility.
• Review and approval of executed batch records in accordance with Alexion’s internal procedures and GMP principles.
• Review and approval of Master Batch Records in accordance with Alexion’s internal procedures and GMP principles.
• Review and approval of Master electronic Batch Record recipes in accordance with Alexion’s internal procedures and GMP principles.
• Review and approval of technical support documentation. (Examples include cleaning, process, method validation).
• Review and approval of functional area documentation (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.
• 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.
• Provide oversight of quality management system activities including Preventive Maintenance, Deviation Management, and the 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 Supplier Management Program.
• Complete review and releasing raw materials and components as required to support manufacturing operations.
• Develop and report quality metrics.

Essential Skills/Experience:

• English fluency written and spoken (the Company language).
• Strong verbal and written communication skills with well-structured communication and presentation ability.
• Ability to operate efficiently in a complex matrix organization and international environment.
• Minimum 3 years in pharmaceutical and/or biotech industry.
• Strong mature leadership and interpersonal influencing skills.
• Sound awareness and understanding of pharmaceutical business, especially with regards to quality and regulatory requirements.
• Academic degree in natural or applied sciences (Pharmacy, Biology, Biotechnology or Engineering).

Desirable Skills/Experience:
• Good analytical, problem-solving, and negotiation skills.
• Cultural Awareness and Positive attitude in managing change.

At AstraZeneca, we are driven by a passion for innovation and a commitment to improving lives. Our unique culture combines the agility of a biotech with the resources of a global biopharma, allowing us to lead the way in rare disease research. We foster an environment where ideas flourish, connections are made, and every day brings new opportunities to make a meaningful impact. Join us in our mission to change lives for the better.

Ready to embark on this exciting journey? Apply now to become part of our team!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.