Pharmaceutical Quality Assurance Associate - Hertfordshire
Lana Premadasa is currently recruiting for a QA Associate to become part of a multinational pharmaceutical company based in Hertfordshire. This role is at the client's custom built facility which houses R&D, Clinical and Manufacturing business units under one roof and is commutable from London, Cambridgeshire and Hertfordshire. The role is offered on a permanent basis with a competitive salary and other benefits.
The key purpose of this role is to ensure Quality Assurance activities relating to product support for the manufacture, packaging, testing, storage and distribution of the organisation and Third Party manufactured drug products are compliant with current GMP and company expectations.
Your main responsibilities in this role will be to:
- Review batch records, associated documents and to approve intermediate product
- Support approval of updated master batch records, QC test methods, label text, Supply Strategy Study Documentation and any associated documents
- Write under supervision, SOPs associated with QA activities
- Participate in internal and external audit process and audit schedules
- Support the preparation and hosting of competent authority inspections
- Support the processes associated with the development and review of Quality Agreements
- Raise and support the investigation of deviations and associated CAPA's
- Raise and support the investigation of customer complaints
- Review qualification/validation protocols and reports
- Support testing the effectiveness of QA's EU product recall procedures on an annual basis
- Support the implementation of change control activities
- Generate and maintain Product Specification Files
- Assist with company supported Investigator Initiated Studies
- Represent the QA at clinical study team meetings cross functional meetings
- Arrange identification testing for imported Investigational Medicinal Products
- Request batch certification and temperature monitoring data
- Provide support to other members of the QA team as appropriate
- Identify and implement Continuous Improvement opportunities that result in cost savings and more efficient and compliant ways of working
- Perform any other appropriate duties at the request of the Director, QA GMP, and to deputise for them, when appropriate
You are required to have the following qualifications, skills and experience:
- Previous experience within a similar working environment is essential
- Basic knowledge and experience of Quality Assurance, Quality Systems, GMP and a basic understanding of manufacture and packaging of pharmaceutical products
- Basic knowledge and understanding of EU clinical trial regulations
- BSc in Life Sciences (or equivalent)
- Good communication skills.
If you are employed by this client you will be joining a global pharmaceutical research company based in Hertfordshire.
For more information or to apply for this position, please contact Lana Premadasa on 01438 842975 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference ST43930 in all correspondence.