We have an exciting opportunity for an experienced Quality Assurance Specialist to work at a Glasgow based CDMO in a fast-paced pharmaceutical production environment. If you have considerable QA experience gained within a pharmaceutical or biotech GMP environment and have a dedicated and thorough work ethic, then we would love to hear from you! Be part of a dynamic and friendly team built on a work culture which fosters collaboration and support. A highly competitive salary and excellent benefits package are on offer in addition to excellent career progression opportunities for the successful candidate.
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 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.
This role involves a high throughput of documents and information to process. Therefore, the Quality Specialist must:
- Hold a Science related qualification, at a minimum of HNC level or equivalent
- 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
Excellent Benefits, with a big focus on employee engagement:
Apply online in the first instance, or contact Liam Baxter at Tel: or email your CV to
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.
We are Disability Confident and neurodiverse aware. If you have a disability, please tell us if there are any reasonable adjustments we can make to assist you in your application or with your recruitment process