Job Description - Quality Assurance Specialist
Curia is a leading global provider of advanced drug development, contract research and manufacturing solutions to the pharmaceutical and biotechnology industries. We have a fantastic opportunity at Curia Glasgow for an 'experienced' Quality Assurance Specialist to join our team. If you have 2 years+ QA experience gained within a similar GMP drug manufacturing pharma environment and have a dedicated and thorough work ethic, then we would very much like to hear from you. In this role, you will assume responsibility for identifying corrections necessary to batch records or other QMS documents and for working closely with operational and laboratory functions to make suggestions to further enhance GMP compliance. You will also be required to provide advice for departments based on GMP and scientific rationale, and at times this will be on a paid "On call" basis. With your knowledge and experience you will be able to review and progress deviations, complaints, investigations, CA/PA in reasonable time frames whilst maintaining your attention to detail. Working as part of a small team, this is a technical position with responsibility for providing a support function to the QA team and ensuring this work is performed in an organised and timely manner. In addition this role will perform administrative and technical Quality Assurance duties, whilst adhering to GMP, COSHH and Health and Safety regulations. Key Job Responsibilities include:
* Documents and reports of all work in adherence with GMP and departmental procedures.
* Performs batch review within the designated timelines described in departmental KPI.
* Authors and reviews SOPs.
* Reviews Type 1 change controls, and green category deviations. Provides feedback / corrections to authors and escalates concerns to the Quality Manager/Head of Quality where necessary.
* Raise CA/PA, approve “other” category CA/PA and review for completion “other” category CA/PA and support the completion of actions through liaison with other departments.
* Represent Quality Assurance in continuous improvement projects ensuring that change is performed in accordance with GMP, site procedures and industry regulations and guidelines.
* Identifies and performs personal development in line with agreed and documented annual goals.
* Assists in the performance of supplier audits, supporting the Lead Auditor.
* Acts as a support to client and regulatory audits, helping with technical support to the audit team and responding to requests for documentation and information.
* Works to a schedule as defined by the Quality Manager / Head of Quality.
* Conducts self-inspection’s / audits to ensure compliance with Quality Management System procedures and GMP regulations.
* Any other task deemed appropriate by line management.
* Ensuring that a timely and effective communication and escalation of quality issues to the appropriate levels of management.
* Carries out site internal audits and identifies areas of GMP improvement during their daily duties.
* Carries out training for QMS activities as defined by line management.
Qualifications
This role involves a high throughput of documents and information to process. Therefore the Quality Specialist must:
* Hold a Science related qualification, degree or a minimum of HND level with QA experience
* Have proven experience within a similar Quality manufacturing environment
* Have a clear understanding of regulatory commitments, e.g. GMP, ICH, COSHH as well as practical experience of GMP procedures, facilities and methods.
* Remain aware of workload levels and priorities within the QA team / other departments and communicate these to senior management in a timely fashion where necessary.
* Have excellent communication skills, ensuring high levels of documentation; legible writing; clear structure
You must already hold the right to work in the UK as we are unfortunately unable to offer sponsorship.
Excellent Benefits, with a big focus on employee engagement.
Up to 9% employer contribution to pension, Dental, Private healthcare, 4x salary life scheme, gym membership contribution, cycle to work, holiday purchase scheme, sick pay, and more
Hours - 37.5 (flexible start/finish times)