Quality Assurance Manager

Ecolab Deutschland GmbH; Neath; On-site; GBP 40,000 - 65,000; Full time

Job summary

A leading company in the Life Sciences sector is seeking a Quality Assurance Manager to oversee quality processes for Medicinal products. The role involves ensuring compliance with regulatory standards and leading continuous improvement initiatives within the organization. Candidates should have significant experience in the pharmaceutical industry and strong project management skills.

Qualifications

• Minimum of 5 years in quality management within pharmaceutical industry.
• Proven track record in managing pharmaceutical Quality systems.
• Strong project management and analytical skills.

Responsibilities

• Develop and maintain the Pharmaceutical Quality System.
• Ensure compliance with UK Human Medicines Regulation.
• Lead cross-functional teams for quality objectives.

Skills

Quality Management

Project Management

Problem-Solving

Analytical Skills

Education

Bachelor’s degree in Pharmacy, Chemistry, Biology, or Engineering

Job description

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.

Continuous Improvement:

• Drive continuous improvement initiatives to enhance product quality and operational efficiency.
• Implement best practices and innovative solutions to improve quality processes and systems, with a focus on meeting MHRA guidelines.
• Analyse quality data and metrics to identify trends and areas for improvement.
• Foster a culture of quality and continuous improvement within the organization.
• Collaborate with internal and external stakeholders to ensure MHRA quality standards are met.
• Communicate risks and issues to senior management and stakeholders.

What you should have:

• Minimum of 5 years of experience in quality management within the pharmaceutical industry or Bachelor’s degree in a relevant field such as Pharmacy, Chemistry, Biology, or Engineering.
• Proven track record in managing pharmaceutical Quality system and leading continuous improvement activities.
• In-depth knowledge of MHRA regulatory requirements and quality standards applicable to the pharmaceutical industry.
• Strong project management skills, including the ability to plan, execute, and monitor projects effectively.
• Excellent problem-solving and analytical skills.

Nice to have:

• Exceptional communication and interpersonal skills, with the ability to work collaboratively with diverse teams.
• Communication skill to support implementation of a quality mind set across departments
• Detail-oriented with a strong commitment to MHRA quality and compliance.
• Proficiency in quality management software and tools.
• Ability to adapt to changing priorities and manage multiple tasks simultaneously in a fast-paced environment.

Our Commitment to a Culture of Inclusion & Belonging
Ecolab is committed to fair and equal treatment of associates and applicants and furthering the principles of Equal Opportunity to Employment. We will recruit, hire, promote, transfer and provide opportunities for advancement based on individual qualifications and job performance in all matters affecting employment, compensation, benefits, working conditions, and opportunities for advancement. Ecolab will not discriminate against any associate or applicant for employment because of race, religion, color, creed, national origin,citizenship status, sex, sexual orientation, gender identity and expressions, genetic information, marital status, age, or disability.