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Senior Quality Assurance Officer

4 months ago

Cambridge Cambridgeshire, United Kingdom CK Group- Science, Clinical and Technical Full time

We are currently seeking a highly experienced and dedicated Senior Quality Assurance Officer to join our Quality Assurance team.

Company Information:

Our client is a growing Contract Development and ManufacturingOrganisation(CDMO) providing GMP manufacturing of ATMPs and related products, process development and ancillary services. We support the development ofcomplex, breakthrough therapies for a globally diverse market. We are at the forefront of revolutionary medicine in which life-threatening diseases are treated usingadvanced therapy medicinal products.

Job Summary:

The SeniorQAOfficer,willbe responsible foroverseeing and ensuring compliancewith relevantregulatoryrequirements and quality standardsthroughout the development, manufacturing, and distribution processes of our advanced therapy medicinal products.

This rolewilltake thelead ondevelopingand implementingquality assurance systemsoverseeingthemanagementof quality records (change controls, non-conformancesdeviations), includingPQS wording.The Senior QA officerwill work closely withAdvent'scross functional teams to drive continuousimprovement,ensuring all records are completed,monitoredand reviewed ina timelymanner.

Key responsibilities will include:

Monitor and ensurecompliancewith relevant regulatory frameworks (GMP, GDP).
Develop andmaintainquality management system documentationincluding policies and procedures.
Providesupport to theQA Managerto ensure that any quality record is assigned to a QA representative, and that stages are completedin a timely manner.
Manage and supervise a team of quality assurance professionals.
Participate in risk assessments and develop strategist for risk mitigation.
Identifyareas for improvement and implement effective quality control measures.
Ensure effective communication with all stakeholders.
Ensuring all our suppliers meet our Company'shigh standardsforqualityand compliance.
Leading andparticipatingin QMS initiatives.

The successful candidatewill havethe following experience/qualifications:

BSc or MSc in a life science subject or comparable experience.
Significant experienceof working in quality assurance within the pharmaceutical or biotechnology industry, in a GMP compliant environment.
Experience of performing external and internal audits.
Strong communicationskills, attention to detail and the ability to workcollaborativelywith cross functional teams.
Comprehensiveknowledgeofregulationsand quality standards relating to ATMPs.

This is a fantastic opportunity to join a growing organisation.We offer an attractive base salary and benefits package.

Apply:

It is essential that applicants hold entitlement to work in the UK. Please quote job reference (phone number removed) in all correspondence #J-18808-Ljbffr