QA Environmental Assurance Officer

Job Description

QA Environmental Assurance Officer

Macclesfield

18 month secondment/FTC/FTO

If you have a science background, knowledge of what it takes to work in aseptic and clean room manufacturing environment, and are looking for your next challenge to become an authority in Environmental Assurance, then this role may be the ideal opportunity for you to develop your skills.

Make a positive impact, in a team where it means more

In Operations we have a big ambition – to deliver more medicines to patients, quicker and more affordably. Backed by the investment, leadership and a clear plan to get there, we bring personal dedication and out of the box thinking.

In Quality, our work is important and valued. An unrivalled forward-looking mentality, there’s no better place to work at the forefront and learn how to add real value to a business throughout the lifecycle of our products – discovery, development and commercialisation.

As the voice of the patient, every batch we certify is a personal stamp of approval. Not something we take lightly, we are always innovating, trialling the latest models and technologies to improve reliability and excellence in our processes.

Macclesfield campus

The Macclesfield site is our second largest manufacturing site and the largest UK based campus, from which our medicines are manufacture, packaged and distributed to over 130 countries globally. You will find an onsite gym, restaurants, parking, on-site holiday childcare and much more!

The role

We now have an 18 month secondment/FTC/FTO opportunity for an Environmental Assurance Officer to join our team.

You'll focus on overseeing the aseptic and clean room operations with respect to physical and microbiological environmental control in production and Quality Control testing facilities.

Dedicated in nature, you will positively support the manufacture of a key oncology product by ensuring the physical and environmental monitoring programme is maintained in compliance with regulations.

As you'll be working in an aseptic environment you should be adherent to a high level of required standards.

Responsibilities:

• Providing support to the production of an aseptically manufactured product in a fast-paced environment.
• Performing a daily assessment of the working environment to support ongoing manufacture. This will include: review of batch records; managing and supporting investigations; provision of technical and practical advice to manufacturing personnel for issue management; and detailed analysis of data to provide compliance reporting.
• Mentoring and training in good aseptic practices.
• Providing good authoritative technical advice on cleanroom subject areas and environmental assurance principles during internal and regulatory inspections.
• Ensuring the safe supply of quality medicines to patients through upholding the required standards for manufacture of aseptic medicinal products.
• Drive continuous improvement activities at AstraZeneca’s Macclesfield Campus.

Essential skills and experience:

• Degree in relevant scientific field or equivalent in experience
• Experience of working in a pharmaceutical manufacturing environment to GMP standards
• Experience or knowledge of clean rooms and their monitoring requirements
• Good understanding of Good Manufacturing Practice (GMP) principles and safety, health and environmental principles in the workplace

Desirable knowledge and experience:

• Ability to analyse issues and develop solutions
• Experience in any of the following areas: authoring and reviewing documentation (e.g. SOPs and technical reports), working within a Pharmaceutical Quality System or supporting audits / regulatory inspections
• Previous experience in a Quality Assurance role
• Knowledge of one or more of the following: Quality Risk Management principles, aseptic technique or microbiological and physical environmental monitoring methods

Why AstraZeneca...

It’s a place to grow a fulfilling and exciting career with constant opportunities resulting from new products, technologies and growing areas like biologics. Our continued growth gives you greater exposure than anywhere else.

Next steps...

Are you ready to bring new ideas and fresh thinking to the table? Excellent! We have one seat available and we hope it’s yours.

Applications are open from 31st August to 12th September 2021.

Competitive salary and benefits