Quality Assurance Officer
Permanent role
Bristol
Competitive salary + package (competitive pension, private medical, generous holidays, income protection scheme/critical illness cover)
Our client is a cutting edge research company working across the life sciences and clinical diagnostics areas.
They are seeking a Quality Assurance Officer (QA) who will work on product quality, customer satisfaction, continuous improvement, environmental impact minimisation and other QA fields.
What you’ll do:
Our client is a world-leading developer of life science reagents, and you will be joining a QA team of four which is currently in place. The role will work in a defined segment of the business on activities detailed below, covering Quality Assurance tasks relating to development and manufacture of Good Manufacturing Practice / GMP and Research Use Only / RUO products.
This is an exciting opportunity for a QA Officer to help maintain the current Quality Systems as well as get involved in continual improvement of these systems.
Key Responsibilities will include:
Batch Record review and product: Review, approval and release of Batch Production Records and Quality Control testing data.Non-conformance: Coordinate and approve/manage to completion any non-conformances, deviations and out of specifications.CAPA: Coordinate and approve/manage to completion any CAPA raised. Ensure adequate root cause analysis has been conducted and any corrections or corrective/preventative actions have been implemented correctly.Documentation Management: Writing, reviewing, and approving internal procedures. Release and issuance of procedures and archiving previous revisions.Change Control: Review and approval of change controls to ensure all changes to procedures and processes are assessed and implemented correctly. Training: Organise and participate in internal quality related training sessions.Internal Audits: Participation in the completion of the internal audit schedule. Conducting the internal audits, reporting any findings, and tracking completion of corrective actions.Supplier Quality: Assist in the QA approval of incoming materials and approval of QC testing for incoming materials. Technical Support: Providing technical support as required in relation to customer enquiries and supporting any associated customer complaint investigations.Any other task as required by the business.
Your Background:
Degree in biology, chemistry, biochemistry, bioengineering, or a related life science field.Experience of working within a Quality Assurance or Quality Systems function for a Pharmaceutical, Medical Device, Life Science or Biotechnology company. Experience of working within a cGMP environment is a top-line requirement for this role (please do detail your experience in your application or covering information).Experience of working to ISO 9001, ISO 13485, 21CFR part 820 or EudraLex Volume 4, Part II.
Further desirable skills we seek:
Experienced in conducting final QA product releaseExperienced in the critical review of Corrective and Preventative Actions / CAPA / non-conformances / deviations / Out Of Specification OOSExperienced in documentation management systems and change control processes from a Quality Assurance perspectiveExperienced internal auditor for ISO 9001, ISO 13485 or cGMP Experienced in supplier quality processesExperienced in investigation of customer complaints and customer technical support Experience of relevant UK and EU regulations governing the purchasing, storage, use and sale of regulated productsExcellent team working skillsAbility to critically review documentationMethodical, process orientated and highly organisedExcellent attention to detailExcellent time management skillsExcellent verbal and written communication skills in EnglishProblem solving abilityFlexible with a can-do attitude
On this occasion, LiCa Scientific is acting as an employment agency.