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QA Batch Release Associate

4 months ago

Liverpool, United Kingdom MSI Pharma Full time

Company Overview:
Join a leading pharmaceutical company dedicated to ensuring the highest standards of quality and compliance in the production of life-saving medicines. We are committed to delivering innovative therapies to patients worldwide and are seeking a passionate and experienced Quality Assurance Specialist to join our dynamic team.

Position Overview:
As a Quality Assurance Specialist, you will play a vital role in ensuring compliance with cGMP regulations and maintaining the highest standards of quality in our manufacturing operations. You will collaborate closely with cross-functional teams to review and compile batch-specific documentation, perform investigations, and drive continuous improvement initiatives to promote a culture of quality excellence.

Key Responsibilities:

Collaborate with QA colleagues to review and compile batch-specific documentation and data for QA Manager/QP release, ensuring compliance with licensed and cGMP requirements. Identify and resolve/escalate issues that may impact batch release, ensuring timely release of batches to meet supply demands. Conduct investigations for product quality complaints (PTC) and adverse events (AE), ensuring timely completion of root cause investigations and escalation of critical issues to management. Actively participate in site quality systems, including deviations, change controls, SOPs, and self-inspections, to maintain cGMP compliance and promote a culture of quality. Drive continuous improvement initiatives by participating in improvement project teams, providing technical support, and implementing best practices. Maintain inspection readiness by ensuring the review, storage, and archive of cGMP documentation and batch records meet regulatory standards. Provide training for own role and keep training records up to date, cross-training in other QO departments as required by the business.

Requirements:

Knowledge of cGMP regulations and background in the pharmaceutical industry. Proven time management skills for planning and scheduling work. Strong communication skills, both written and verbal. Ability to work effectively as part of a team while also being flexible to work independently. Experience with Quality Management Systems and computer literacy. Fluency in English. Bachelor's degree in a relevant discipline or equivalent experience within the industry. Experience working in a cGMP environment and familiarity with Quality Assurance systems and procedures are desirable.

Join Our Team:
If you are passionate about quality, compliance, and making a difference in the lives of patients, we invite you to join our team. Apply now to become a part of our mission to deliver high-quality medicines to those in need.