Ecolab is looking for a Quality Assurance Manager. This is a critical role responsible for overseeing and ensuring the quality processes that support the manufacture of Life Science and Medicinal products. This includes planning, executing, and monitoring quality-related activities to ensure compliance with regulatory standards, as well as company policies.
The Quality Assurance Manager works closely with cross-functional teams to drive continuous improvement and maintain the highest standards of product quality.
The Quality Assurance Manager will report directly to the Head of Technical Quality. Regular updates on Pharmaceutical Quality system status, risk assessments, and quality metrics will be communicated through detailed reports and presentations. The role involves Embedding quality processes into the routine manufacturing processes that are completed at Ecolab - Baglan.

What you will do:

• Develop, implement, and maintain the Pharmaceutical Quality System (PQS) in accordance with ISO 9001, ICH Q10, and other relevant regulatory requirements.
• Ensure compliance with UK Human Medicines Regulation 2012 (SI2012/1916 as amended), the Orange Guide, and EudraLex.
• Oversee the development and implementation of Standard Operating Procedures (SOPs), work instructions, and forms or records.
• Prepare for and manage external audits, including those conducted by regulatory bodies and customers.
• Manage quality risk assessments and ensure that Quality Risk Management principles are applied throughout the organization as per ICH Q9 requirements.
• Manage core PQS processes. Conduct internal audits and Customer Audit.
• Lead cross-functional teams to ensure quality objectives are met and foster a culture of continuous improvement.
• Provide technical guidance and support to internal departments.
• Ensure compliance with all relevant regulatory requirements, particularly MHRA standards, as well as FDA, EMA, and other international regulations.
• Support inspection readiness activities and meetings including relevant stakeholders.
• Develop and implement quality management systems and processes to support product development, manufacturing, and distribution.
• Conduct regular self-inspections to identify areas for improvement and ensure adherence to MHRA quality standards.
• Lead investigations into quality issues, deviations, and non-conformances, and document findings and corrective actions.
• Support and facilitate customer audits by providing relevant documentation, coordinating audit schedules, and addressing any customer concerns or inquiries
• Undertake additional tasks and responsibilities as assigned by the line manager to support evolving team and organizational needs.

• Develop, implement, and maintain the Pharmaceutical Quality System (PQS) in accordance with ISO 9001, ICH Q10, and other relevant regulatory requirements.
• Ensure compliance with UK Human Medicines Regulation 2012 (SI2012/1916 as amended), the Orange Guide, and EudraLex.
• Oversee the development and implementation of Standard Operating Procedures (SOPs), work instructions, and forms or records.
• Prepare for and manage external audits, including those conducted by regulatory bodies and customers.
• Manage quality risk assessments and ensure that Quality Risk Management principles are applied throughout the organization as per ICH Q9 requirements.
• Manage core PQS processes. Conduct internal audits and Customer Audit.
• Lead cross-functional teams to ensure quality objectives are met and foster a culture of continuous improvement.
• Provide technical guidance and support to internal departments.
• Ensure compliance with all relevant regulatory requirements, particularly MHRA standards, as well as FDA, EMA, and other international regulations.
• Support inspection readiness activities and meetings including relevant stakeholders.
• Develop and implement quality management systems and processes to support product development, manufacturing, and distribution.
• Conduct regular self-inspections to identify areas for improvement and ensure adherence to MHRA quality standards.
• Lead investigations into quality issues, deviations, and non-conformances, and document findings and corrective actions.
• Support and facilitate customer audits by providing relevant documentation, coordinating audit schedules, and addressing any customer concerns or inquiries
• Undertake additional tasks and responsibilities as assigned by the line manager to support evolving team and organizational needs