QA Associate

Your mission

The QA Associate will play a critical role in ensuring that our products meet the highest standards of quality and compliance with regulatory requirements. The ideal candidate is passionate about quality and has a strong desire to continuously improve processes. They must thrive in a fast-paced environment and work well under tight deadlines. A strong understanding of cGMP and experience in the pharmaceutical or biotech industry are essential.

Job Description

Major Activities and Responsibilities:

• Provide QA oversight for MeiraGTx London operations, including manufacturing shifts and supporting functions.
• Generate, review, and approve GMP documentation.
• Assist in developing and implementing quality policies and procedures.
• Maintain QA KPI metrics.
• Collaborate with other departments to ensure quality and compliance across operations.
• Review and approve batch documentation for completeness, accuracy, and compliance with cGMP and company procedures, ensuring timely release of GMP-compliant products.
• Support QA team during facility walk rounds and operational QA support.
• Assist during customer and regulatory audits.
• Participate in internal audits and inspections, and prepare audit reports.
• Manage quality systems, including reporting, investigations, root cause analysis, risk assessments, incidents, deviations, CAPAs, change controls, and temperature excursions.
• Support document management activities as needed.
• Promote continuous improvement of the Quality Management System.
• Conduct training on cGMP and quality systems for employees.
• Provide guidance on quality issues in operational areas and to third parties.

Key Job Competencies

• Attention to detail in identifying and analyzing quality issues.
• Strong knowledge of cGMP standards.
• Analytical skills for data collection and trend analysis.
• Problem-solving skills for developing compliant solutions.
• Technical proficiency with quality management systems and relevant software.
• Effective communication skills across departments.
• Teamwork and relationship-building abilities.
• Time management skills to prioritize tasks and meet deadlines.
• Ensure compliance with GMP, Data Integrity, and GDP practices.
• Timely completion of training and documentation tasks.

Background

• Bachelor's degree in Chemistry, Life Sciences, or related technical discipline preferred.
• At least 1 year of GMP manufacturing and Quality Assurance experience.
• Knowledge of sterile manufacturing is a plus.
• Proficiency with electronic QMS systems.
• Excellent communication skills, both verbal and written.