Overview
Job Description We are seeking an experienced and dedicated Quality Assurance professional to lead the implementation and maintenance of our Quality Management System (QMS) in full compliance with pharmaceutical GMP, and Food and Feed quality standards. In this pivotal role, you will manage the QA Systems team, oversee key quality systems activities, and ensure our products consistently meet the highest standards of quality, safety, and regulatory compliance.
Responsibilities
* Management of the QA Systems Team: Lead and mentor the QA systems team, providing direction, guidance, and support, fostering a culture of quality and compliance within the team and across site.
* Site Quality Management System (QMS): Maintain the site QMS in accordance with EU/UK GMP requirements, and Food and feed quality standards. Continuously assess and enhance the QMS to drive operational excellence and compliance.
* Site Audit Programme: Develop and execute an audit programme to ensure adherence to EU/UK GMP and Food and Feed quality standards and company policies. Coordinate internal and external audits and regulatory inspections.
* Supplier Approval and Management: Establish and maintain a robust supplier approval process, including risk assessment and performance evaluation. Collaborate with cross-functional teams to address supplier quality issues and ensure a secure supply chain.
* Management of Contract Manufacturing Organisations (CMOs): Oversee quality agreements and quality oversight of CMOs to ensure the production of high-quality products. Monitor CMO performance and manage continuous improvement initiatives.
* Hosting Regulatory Audits: Prepare for and host regulatory inspections and audits, maintaining a state of inspection readiness.
* Collaborate cross-functionally to address findings and implement CAPA.
* Customer Complaints: Manage the investigation, resolution, and trending of customer complaints related to product quality.
* Implement corrective actions to prevent recurrence and enhance customer satisfaction.
* Management Review: Facilitate and coordinate management review of the QMS, ensuring that senior leadership is informed of the system's performance.
* Document Control: Establish and maintain an effective document control system, ensuring that all quality-related documents are up-to-date, accessible, and compliant.
* HACCP: Develop and maintain an effective HACCP, TACCP and VACCP risk control system for food safety.
* Quality Metrics: Develop and maintain key performance indicators (KPIs) to measure and report on QMS performance.
Qualifications
* Bachelor’s degree in a relevant field
* A minimum of 4 years’ experience in pharmaceutical quality assurance, including 2 years in a supervisory or management role.
* Strong knowledge of EU/UK GMP regulations and their application in a pharmaceutical manufacturing environment.
* Excellent communication, leadership, and problem-solving skills.
* Detail-oriented with a focus on continuous improvement
* Proficiency in using quality management software and electronic document management systems.
* Ability to handle multiple projects and priorities simultaneously.
Future Perspective
* Challenging tasks, short decision-making processes and a high level of personal responsibility in a modern work environment with flexible work time models.
* Room for innovative thinking and growth with the possibility to manage your own career path.
* A company culture which promotes continuous learning and diversity. To assist with this all colleagues can join our Women’s and Multicultural Employee Resource Groups, and the ADM Pride Employee Network and the Young Professionals Network. As well as the company wide mentorship programme as mentor or mentee.
* Excellent career opportunities in a world leading nutrition company.
* An attractive remuneration.
* ADM is a company where managers and colleagues are encouraged to discuss and enable the flexibility that is needed to meet the demands of work and life.
* ADM are an advocate of having a workforce who are aware of their mental health. In addition to our network of Mental Health First Aiders, all new starters to the business will be enrolled in ‘Mental Health Aware’ training within three months of joining the business.
Req/Job ID
105532BR
Ref ID
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