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Head of Quality, Safety and Assurance
2 months ago
Proclinical is seeking a dedicated GMP Quality Assurance Manager. This role is pivotal in ensuring the safety of all pharmaceutical products as well as ensuring they are in compliance with regulatory requirements and up to industry standard. The successful candidate will collaborate with various internal departments and external contractors to maintain high standards of product quality.
Participate in the maintenance of the Quality Management System (QMS) in compliance with regulatory standards.
Conduct internal/external audits and participate in regulatory inspections.
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 process 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.
Bachelor's degree in Pharmaceutical science, Biologics, Biotechnology, Biochemistry, or a related field. Experience in quality assurance within the pharmaceutical industry.
Ability to manage multiple projects and priorities in a fast-paced environment.
Agile thinker who can adapt to situations of high-speed change.
