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Senior QA Release Officer
3 months ago
About Us
Allergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.
Our adjuvant technologies not only advance the results of allergy immunotherapy but also drive beneficial immune responses in cancer and infectious disease.
We are a proud and passionate team with a vision that delivers growth and transforms the way we think about immunology.
You'll join a team of like-minded people who are passionate about what they do and providing positive outcomes for our patients.
We are looking for a Senior QA Release Officer to provide quality guidance and support for manufacturing, production and packaging operations.
The role also acts as the point of contact cross functionally with regard to quality release questions, providing support for external GMP requirements and providing data integrity support.
About you
You will be experienced within a similar role having gained this experience within a pharmaceutical manufacturing environment, with a minimum of 2 years' experience in a GMP environment (in line with regulations).
You will be a confident communicator who is calm under pressure and comfortable working with a number of stakeholders.
We are looking for someone who can provide guidance for the team and also work closely with the QA Manager to support GMP compliance.
The role
You will be involved in the following:
- Reviewing and releasing of products manufactured under our Specials License
- Ensuring timely review of all bulk, finished product and specifics batch documentation for QP release
- Preparation of Certificate of Analysis
- Acting as the QA point of contact for cross functional queries with regards to batch release and review.
- Managing day to day workload within the team
- Acting as champion for investigations and assisting QA Manager in improving and ensuring root causes assessed adequately
- Ensuring the continued support and compliance to QA systems in terms of change control, nonconformances, customer complaints and annual product review
- Providing Quality guidance in support of site operations
- Supporting compliance with all GMP regulations as instructed by QA Manager
- Maintaining up to date knowledge of current industry practices for quality systems
Job Types:
Full-time, Permanent
Salary:
Up to £33,000.00 per year
Benefits:
- Company pension
- Cycle to work scheme
- Flexitime
- Health & wellbeing programme
- Life insurance
- Onsite parking
- Private medical insurance
- Referral programme
Schedule:
- Flexitime
- Monday to Friday
Application question(s):
- Do you have at least 2 years experience within a QA role in a GMP environment?
- Do you have experience with Batch Release?
Work Location:
In person