Qc Application Specialist - Liverpool, United Kingdom - AstraZeneca

AstraZeneca

Verified Company

Liverpool, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

QA Application Specialist - 12 Month Secondment / Fixed Term Contract
Speke

Build a long-term career by unlocking opportunities for lifelong learning
Build unrivalled capabilities in a place that promotes learning agility and offers development opportunities. We never stand still so you'll have the chance to constantly grow your abilities, skills and knowledge. Here we are a fusion of challenging and interesting work, in an energising and inspiring environment.

Make a meaningful impact on people's lives with life-changing medicines
Join the team where everyone feels a personal connection to the people that we impact. From our science labs to manufacturing at scale, we are committed to delivering at the highest quality. It's inspiring and rewarding work, influencing every part of the product lifecycle to deliver life-changing medicines. To ultimately make people's lives better - from patients and their families to all of us in society.

Speke is where biologics comes to life.

We have the facilities to research, develop, produce and distribute up to 20 million vaccine doses a year for the global market.

We all know each other, which creates a community atmosphere. You'll always feel welcome at Speke. The comradery and good humour between staff on site is fantastic to be a part of.

The Quality Technical team are looking to recruit a QC Application Specialist on a 12 month secondment / fixed term contract to support the management and administration of global QC computerised systems, that are critical to supporting High Performing Labs (HPL), digital uplift and ensuring golden batch adherence - releasing product to patients on time in full.

What you'll do:

Coordinate the local management and administration of global Quality Technical including: QCLIMS, MODA and Empower.

Support the development and implementation of new informatics solutions into Liverpool QC.

Collaborate with the local business functions on project management, continuous improvement, OE and data integrity for all systems.

Assist in the creation and maintenance of multi-site documentation and other associated documentation related to Quality Technical e.g. LIMS, MODA and Empower.

By monitoring QC computerised systems, you'll ensure compliance to regulatory requirements, such as 21 CFR Part 11, and Annex 11.

Essential skills & experience:

Experience of a variety of software and integrated complex systems in a quality and compliance environment such as LabWare LIMS, Lonza MODA and Waters Empower
Good knowledge and understanding of the principles and concepts of compliance management and Good Manufacturing Practice / Good Laboratory Practice
Creativity, problem solving and independent decisionmaking skills
Good writing and documentation skills
Good communications skills, time management, diplomacy and the ability to work under pressure are also crucial
Strong presentation skills with the ability to optimally communicate to all levels within the organisation.
Experience of delivering significant change projects in a quality environment is desirable
A good understanding of QC methods, be conversant with the USP, ICH and European Pharmacopoeias and demonstrate a knowledge of industry standards for pharmaceutical product testing
Knowledge of Computer Validation processes applicable to QC such as knowledge of IT Validation, GAMP, Annex 11, Electronic records and electronic signatures

Working days are: 08:00-16:45 Monday -Thursday, 08:00-13:00 Friday.

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 envisioning yourself in this role? Good, because we can't wait to hear from you

Competitive Salary and Benefits

Opening Date: 08/06/2023
**Closing Date: 22/06/2023