Hobson Prior is working with a leading biotechnology company who are in search for a Senior QA Associate to join them on a permanent basis in London. This role will provide QA support and oversight at the organisation and will ensure of QA regulatory compliance and product quality requirements are met at all times, as well as facilitating product release in a timely manner.

Job Responsibilities:

• Coach and train the QA team and continuously improve the local Quality system and provide training & support for Quality relevant systems.
• QA oversight to the manufacturing operation and supporting functions.
• Management of the organisation's Quality Management System.
• Generation, Review and approval of relevant GMP documentation.
• Create QA Processes. Create Standard Operating Procedures, Policies and Training material.
• Maintain QA KPI metrics.
• Collaborate with Operational areas, supporting the Team Lead to manage the day-to-day QA Operations.
• Review Batch documentation and support QA team review of Batch documentation. Ensuring timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
• Manage and support QA team Facility walk rounds and QA support for all operational areas.
• Provide direct quality team support during customer and regulatory audits.
• Perform internal audits and inspections and audit write up.
• Quality Systems: Complete Reporting, reviewing, investigating, root cause analysis, assessing Quality risk assessments, Incidents, Deviations, CAPA's, Change Controls and temperature excursions.
• Create and review Risk reporting and Mitigation.
• Any other assigned duties.

Key Skills:

• Robust interpersonal skills.
• Good organisational and time management skills and able to demonstrate flexibility and adaptability.
• A good team player with the ability to work self-sufficiently.
• Able to prioritise workload, decisive thinker able to work within agreed timescales.
• A high Level of attention to detail.
• Excellent verbal and written communication skills.

Requirements:

• An excellent understanding of Quality Management Systems.
• IT literate, experience managing and operating an electronic QMS.
• You are proficient in Microsoft Office and experience in database use and eQMS systems.
• Previous experience of working within a sterile GMP manufacturing environment.
• Knowledge of GCP and GMP with regards to QMS activities
• Previous experience in Competent authority, Regulatory body inspections and audits.
• Previous experience working in a GxP environment including a minimum 5 years' experience in Compliance and Quality Assurance.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.