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GMP Compliance Specialist

2 months ago

surrey, United Kingdom Proclinical Staffing Full time

Job Summary:

Proclinical Staffing is seeking a dedicated Quality Assurance Manager to ensure the safety and compliance of pharmaceutical products. This role is pivotal in maintaining high standards of product quality and regulatory compliance.

Key Responsibilities:

  • Participate in the maintenance of the Quality Management System (QMS) in compliance with regulatory standards.
  • Conduct internal/external audits and participate in regulatory inspections.
  • Ensure all products comply with relevant regulations and guidelines.
  • Prepare for and participate in regulatory inspections and audits.
  • Oversee the preparation, review, and approval of quality-related documentation.
  • Conduct risk assessments and implement risk mitigation strategies.
  • Manage the investigation and resolution of quality issues.
  • Provide training and development opportunities on QA processes to the company.
  • Collaborate with cross-functional teams to ensure product quality throughout the product lifecycle.
  • Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency.

Requirements:

  • Bachelor's degree in Pharmaceutical science, Biologics, Biotechnology, Biochemistry, or a related field. A Master's is preferred.
  • Experience in quality assurance within the pharmaceutical industry.
  • Strong knowledge of Good Manufacturing Practices.
  • Excellent communication and interpersonal skills.
  • Ability to manage multiple projects and priorities in a fast-paced environment.
  • Agile thinker who can adapt to situations of high-speed change.
  • Problem solver who can work through complex issues.
  • Demonstrates a willingness to achieve goals together and respect the view of others.