The main purpose of the role will be to:
Provide assurance that manufacturing is carried out in accordance with cGMP and regulatory commitments for external contract manufactured product.
Further responsibilities will include:
Ensure cGMP compliance through execution of the approved Quality Agreement with Contract Manufacturers and provide advice on continuous quality improvement aspects as per ICH Q10.
Monitor trends and identify problems in quality of purchased materials, packaging, intermediates, finished products, water and environmental data and promote corrective/ preventative actions.
Write/revise quality documentation e.g. batch production records, specifications, procedures, stability protocols and reports, change controls, deviations, complaints, annual product reviews and quality agreements.
Support the disposition raw materials, including packaging items, intermediates and finished products according to the available data.
Manage complaint investigations to ensure completion to required timelines.
Support the Hub archive process.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
A Degree in a Scientific (BSc/ BSc (Hons) minimum or equivalent) or Engineering discipline with experience in a pharmaceutical cGMP environment.
Pharmaceutical QA experience is essential.
Proven ability to understand and interpret process/ analytical data. Multi-tasking and priority/ time management skills are essential. Excellent interpersonal skills with the ability to work as an individual or as part of a close working team and delivering on business objectives.
Experience in a pharmaceutical cGMP manufacturing environment would be advantageous.
Flexibility in travel to support business deadlines and customer requirements (likely to be restricted in Western Europe with one/two days away only).
This is an excellent opportunity to join a global company in the Liverpool area.
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 KA41331 in all correspondence.