QA Specialist

4 days ago


Glasgow, United Kingdom FPSG Full time

**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.

**Qualifications**:
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**:
**Next Steps**:
***

**Equal Opportunities**:
FPSG is committed to equal opportunities regardless of gender, race, disability, sexual orientation, religion or belief and age.



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