Quality Assurance Associate (QMS)

1 day left

Macclesfield, England, Cheshire
05 Jan 2021
19 Jan 2021
AstraZeneca UK
Quality, QA / QC
Full Time
Contract Type
Experience Level
Experienced (non-manager)

Do you have expertise in Pharmaceutical Quality Systems and passion for Supply Chain and production process? If so we may have the ideal role for you!

At AstraZeneca, we believe in the potential of our people and you'll develop beyond what you thought possible. We make the most of your skills and passion by actively supporting you to see what you can achieve no matter where you start with us.

At AstraZeneca the only one who can put limits on the scope of your career is you. With the right skills and passion we'll help you explore what AstraZeneca has to offer.

We now have an outstanding opportunity for an experienced Quality Professional. Reporting into the Quality Assurance Group Manager aligned to Sourcing & Supply. We're seeking a motivated individual with a proven level of technical process understanding and expert knowledge of Pharmaceutical Quality Systems (PQS).

As the Quality Assurance Associate (QMS) you'll be responsible for the development and management of all QA Third Party Supply (3PS) activities across our Macclesfield campus.

  • We'll expect you to maintain a high-level understanding of End-to End Supply Chain, production processes and quality systems. You'll be a primary site QA point of contact for issue management with Third parties.

  • This role involves regular dialogue with third party companies' QA explaining quality issues, advising of changes, agreeing and signoff of QA Agreements. You'll have the ability to convey complex information to individuals who will have no or limited knowledge of AZ processes / QMS / manufacturing.

  • You will support a network of Quality Assurance Associates in their day to day role (business area QAA alignment to 3PS)

  • You will be the main site QA contact for Global 3PS organisation (including aligned QA)

  • You'll ensure QA business processes support the compliant and efficient execution of obligations between AZ and Third Parties. This will include compliance with Annex 16 of the EU GMP Guide.

  • Experienced in managing risk, you will use evaluative judgement in complicated or novel situations.

  • You'll participate in regulatory inspections where Third Party Supply is in scope. We'll want you to have direct involvement in third party audits of Macclesfield Operations.

  • By collaborating with and influencing other Quality professionals across the organisation, we'll ensure consistent application and execution of key quality systems.

  • Proactive by nature, you will look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whilst ensuring an appropriate level of compliance.

  • You will have a passion for Continuous Improvement and a strong understanding of Lean Manufacturing.

  • Knowledgeable of evolving regulatory compliance practices and recommends implementation strategies to QALT, you will share and build standard methodology as appropriate.

  • We'll ask you to collaborate in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility.

Experience required:

You'll hold a Degree or equivalent professional qualification in a science or technical field such as Pharmacy, Chemistry, Biology or Engineering.

With prior experience in Good Manufacturing Practice, you'll understand international GMP requirements /quality systems and Pharmaceutical manufacturing/packing and testing technologies. You will also have extensive knowledge of and application of cGMP requirements of Quality Management Systems.

With a strong technical process background across a variety of manufacturing areas, we'll need a solid understanding of regulatory interactions and compliance procedures and ability to apply this in an operations environment.

With strong influencing and negotiating skills, we're expecting a high level of customer focus and strong ability to reinforce and maintain quality standards.

We are looking for a confident communicator who is able to build relationships both internally and externally.

Experience of working with Third Party Suppliers and of different companies Quality Management Systems would be beneficial.

If you are interested in this exciting opportunity, apply today!

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