Senior QA Officer
Bristol, England
Permanent Role
Reporting to the Quality Assurance (QA) Team Leader, your role will be instrumental in coordinating and leading the daily operations of the business, maintaining compliance with Quality Assurance requirements across all product types and business areas. The focus is on leading activities that support Cell and Gene Therapy (CGT) manufacturing schedules. You will also mentor and coach other QA Officers in quality requirements and business practices.
What You'll Do
As our Senior QA Officer, you'll have responsibilities including:
- Leading QA activities that support the CGT manufacturing schedules.
- Leading the review, approval, and release of Batch Production Records and
- Quality Control testing data.
- Coordinating and approving/managing to completion any non-conformances, deviations, and out of specifications.
- Coordinating and approving/managing to completion any Corrective and Preventative Actions (CAPA) raised, ensuring adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.
- Managing documentation, including writing, reviewing, and approving internal procedures; releasing and issuing procedures; and archiving previous revisions.
- Reviewing and approving change controls related to CGT manufacturing and product quality, ensuring all changes are assessed and implemented correctly.Acting as an experienced internal auditor for ISO 9001, ISO 13485, or cGMP.
- Supporting preparation activities and backroom operations during external/customer audits.
- Working closely with Quality, Manufacturing, Supply Chain, and Facilities teams to identify and support Quality System compliance and customer needs, using initiative and adapting to shifting priorities.Leading internal quality-related training sessions for the business.
- Acting as an experienced professional in product disposition and release.
- Acting as an experienced professional in the critical review of CAPA / non-conformances / deviations / Out of Specification (OOS).
- Acting as an experienced professional in documentation management systems and change control processes from a Quality Assurance perspective.
- Coaching and mentoring team members on quality assurance and business requirements, including best practices.
- Fostering and supporting a culture of high performance, creativity, teamwork, values.
- Undertaking any other task as required by the business.
Your Background
- Experience in the critical review of CAPA / non-conformances / deviations / OOS.
- Experience in documentation management systems and change control processes from a Quality Assurance perspective.
- Experienced internal auditor for ISO 9001, ISO 13485, or cGMP.
- A highly collaborative and proficient individual with excellent communication skills.
On this occasion LiCa Scientific is acting as the recruitment agency. Thank you in advance for your interest!