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 be able to thrive in a fast-paced environment and be comfortable working under tight deadlines. They will have a strong understanding of cGMP and have experience in the pharmaceutical or biotech industry.
Job Description
Major Activities and Responsibilities:
- Provide QA oversight for MeiraGTx London operations. This includes the manufacturing shift pattern and supporting functions.
- Generation, review and approval of relevant GMP documentation.
- Assist with the development and implementation of quality policies and procedures.
- Contribute to the maintenance of QA KPI metrics.
- Collaborate with other departments to ensure quality and compliance are maintained across operations.
- Review and approve batch documentation for completeness, accuracy, and compliance with cGMP and company procedures. Ensure timely and adequate release of GMP compliant product in accordance with Regulatory and site-specific authorisations.
- Support QA team facility walk rounds and QA support for all operational areas.
- Provide direct quality team support during customer and regulatory audits.
- Participate in internal audits/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.
- Support Document Management activities when required.
- Proactively initiate and support continuous improvement of the Quality Management System.
- Conduct training sessions for employees on cGMP and quality systems.
- Provide guidance and assistance to quality related issues in Operational areas and to third parties.
Key Job Competencies- Attention to detail: The ability to identify and analyse quality issues with precision and accuracy. QA Associates must be meticulous in their work, ensuring that all products and documentation meet the highest quality standards.
- Knowledge of cGMP: A strong understanding of current Good Manufacturing Practice and to ensure that products are manufactured in compliance with industry standards.
- Analytical skills: QA Associates must be able to collect and analyse data to identify trends and potential quality issues. They must be able to use this information to make informed decisions and recommend corrective actions.
- Problem-solving skills: QA Associates must be able to think critically and develop compliant solutions for quality-related hurdles.
- Technical proficiency: Experienced in the use of quality management systems and computer software programs used in the pharmaceutical and biotech industries.
- Communication skills: Must be able to effectively communicate complex issues to colleagues at different levels and in different departments.
- Teamwork: Able to work effectively as part of a team and build strong relationships with colleagues to achieve common quality goals.
- Time management: QA Associates should be able to manage their time effectively, prioritize tasks, and meet deadlines. They must be able to work efficiently and effectively under pressure, without sacrificing the quality of their work.
- Responsible for ensuring that own work complies with GMP, Data Integrity and Good Documentation Practice (GDP) and is undertaken in accordance with applicable procedures
- Responsible for ensuring that own training is undertaken in a timely and GMP compliant manner before the task is undertaken
- Responsible for ensuring that any GMP documentation assigned to me e.g. (but not limited to) Issues, CAPAs, Change Controls, BMRs & audit/inspection actions is closed timely and in a RFT state
Background- Bachelor's degree in a scientific field such as Chemistry and Life Sciences or other technical discipline is preferable.
- Experience working in a GMP manufacturing environment including a minimum 1 years’ experience in Compliance and Quality Assurance.
- Knowledge of sterile manufacture is preferable.
- IT literate, experience managing and operating an electronic QMS.
- Excellent verbal and written communication skills are essential.
Why us?