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QA Specialist

FPSG Connect
Job LocationGlasgow
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent , full-time

Job Description

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 environmentand 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 offerin 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-inspections / 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:Apply online in the first instance, or contact Liam Baxter at Tel: or email your CV toEqual Opportunities: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

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