Quality Assurance Officer - 2 year FTC
Be the voice of the patient
Be proud to play a critical role as the eyes and ears of our patients. Unafraid of the responsibility, we monitor and sign off each batch as if the medicine were for our own family. All our contributions add up to improving the quality of patients’ healthcare and ultimate their quality of life.
We now have a fantastic opportunity for a Quality Assurance Officer to join our team.
What you'll do
Aligned to the packing and sold dose manufacturing area, you will work within the new Global Packing Centre which is a modern packing facility and provide support to the upgraded tablet formulation area. As direct Quality support to these manufacturing areas we need to ensure all products released for sale or further processing complies with cGMP standards, product quality specifications and regulatory requirements.
Key duties will include review and approve related technical / GMP documents and collate and interpret data such as quality key performance indicators, analytical results/trends and regulatory compliance documentation, validation and engineering information.
Provide independent assurance of the maintenance of the appropriate quality standards within this area, whilst supporting timely and effective resolution of all quality issues to maintain product flow across the factory
Responsible for making product and material release decisions, operating within global standard pack ahead of clearance (PAOC) and ship ahead of clearance (SAOC) guidelines
Providing leadership and support for internal and external inspection preparations as well as significant audits to aid in developing improvement plans, monitoring any actions to ensure ongoing compliance
Advising on deviations using professional discernment to make batch disposition recommendations to approve or reject a product. And provide expert advice to the area on Good Manufacturing Practice /Good Distribution Practice within the site, with reference to GMP guidelines and regulations.
Ensuring compliance with change management processes within your area you'll actively look for opportunities to identify and lead change and make efficiency savings, influence decisions and deliver results whilst ensuring compliance is maintained appropriately
Help deliver Manufacturing Excellence by participating in our Global Lean Framework
Essential Skills & Experience:
Degree or equivalent professional qualification in a science / technical field such as Pharmacy, Chemistry or Biology
Prior experience in Good Manufacturing/Good Distribution/Good Laboratory practice and/or compliance management
A level of technical process understanding in manufacturing or packing or warehouse/distribution or Quality Control
Knowledge of and application of quality systems, including change control, deviation management and New Product Introductions
Awareness /knowledge of regulatory interactions and compliance procedures and ability to apply this in an operations environment
Knowledge of other areas of the Supply Chain, including groups such as regulatory, Global Quality, Manufacturing, Supply and Capability etc.
Experience of working in a Lean environment, and knowledge of Lean principles and tools would be of benefit, but not crucial
There are so many fantastic employee benefits that AstraZeneca offer! A competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.
So, what’s next…
Are you already imagining yourself in this role? Good, because we can’t wait to hear from you!
We look forward to receiving your application no later than midnight Monday 29th August
Competitive Salary and Benefits
Opening Date: 20/12/2022
Closing Date: 09/01/2023
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Date Posted
21-Dec-2022Closing Date
20-Dec-2022AstraZeneca 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.
