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Senior QA Release Officer

4 months ago

Worthing, United Kingdom Allergy Therapeutics Full time

**About Us**

Allergy Therapeutics are a market leading, pioneering immunology business with specialist experience in the research and development of allergy treatments.

We believe that transformational outcomes for patients are achieved by directly treating the cause, rather than just managing symptoms. Our vaccines are aluminium free. Driving convenience; our ultra-short course treatments make life easier and increase adherence.

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.

We are continuing to grow and it’s an exciting time to be joining us. You will contribute to our ongoing success and be part of our future which is looking very bright

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. As part of the role you will release products manufactured under our Specials License. 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). This experience will ideally have been gained in a steriles manufacturing environment.

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, non-conformances, 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
- On-site 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