Quality Assurance Specialist
Posted 1 week ago by SRG
Negotiable
Undetermined
Undetermined
Glasgow, Scotland, United Kingdom
Summary: SRG is seeking a Quality Assurance Specialist for a global pharmaceutical company. The ideal candidate will have experience in Quality Assurance within a GMP environment and will be responsible for various QA tasks including batch reviews, SOP documentation, and supporting audits. The role offers opportunities for growth and development within the company.
Key Responsibilities:
- Perform batch reviews within required timelines
- Author and review SOPs
- Document and report all work in adherence with GMP and departmental procedures
- Review change controls and provide feedback/corrections to authors and escalate concerns to the Quality Manager/Head of Quality where necessary
- Raise, approve and review CAPAs
- Represent the QA team for improvement projects and with clients and internal teams
- Assist in the performance of supplier audits, supporting the Lead Auditor
- Act as a support to client and regulatory audits, helping with technical support to the audit team and responding to requests for documentation and information
- Conduct self-inspections/audits to ensure compliance with Quality Management System procedures and GMP regulations
- Ensure timely and effective communication and escalation of quality issues to the appropriate levels of management
- Carry out site internal audits and identify areas of GMP improvement during daily duties
- Carry out training for QMS activities as defined by line management
Key Skills:
- Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
- Several years’ experience within Quality Assurance working to GMP guidelines
- Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations/Investigations/CAPA)
- Experience of preparing and assisting in external audits with regulatory bodies such as FDA and MHRA
- Organised and attention to detail
- Strong communication skills across all levels
Salary (Rate): undetermined
City: Glasgow
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
SRG are working with a global name in the pharmaceutical industry to help them find a QA Specialist to join their team. If you have Quality Assurance (QA) experience from a GMP environment then this could be a great next step for you. The company offer an excellent benefits package and scope for growth and development.
The Role:
- Perform batch reviews within required timelines
- Author and review SOPs
- Document and report all work in adherence with GMP and departmental procedures
- Review change controls and provide feedback / corrections to authors and escalate concerns to the Quality Manager/Head of Quality where necessary
- Raise, approve and review CAPAs
- Represent the QA team for improvement projects and with clients and internal teams
- Assist 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
- Conducts self-inspections / audits to ensure compliance with Quality Management System procedures and GMP regulations
- 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
Requirements:
- Degree in a relevant scientific, engineering or business discipline and/or relevant industry experience
- Several years’ experience within Quality Assurance working to GMP guidelines
- Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations /Investigations /CAPA)
- Experience of preparing and assisting in external audits with regulatory bodies such as FDA and MHRA
- Organised and attention to detail
- Strong communication skills across all levels