Qa Batch Release Associate

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.