Senior Quality Specialist - Pharmaceutical - South West

• Quality Assurance Leadership: Lead quality assurance initiatives and ensure compliance with regulatory standards such as FDA, EMA, and other relevant authorities.
• Process Improvement: Identify areas for process optimization and implement strategies to enhance efficiency and quality across all stages of pharmaceutical production.
• Documentation and Compliance: Oversee documentation processes, including SOPs, batch records, and regulatory submissions, to ensure accuracy, completeness, and compliance with industry standards.
• Quality Control Oversight: Collaborate with cross-functional teams to develop and implement robust quality control measures, including risk assessments, investigations, and corrective/preventive actions.
• Training and Development: Provide guidance and training to team members on quality assurance protocols, regulatory requirements, and best practices within the pharmaceutical industry.
• Audit Preparation and Management: Coordinate internal and external audits, participate in inspections, and facilitate the resolution of audit findings to maintain compliance and uphold quality standards.

• Bachelor's degree in Pharmacy, Chemistry, Biology, or related field; advanced degree preferred.
• Minimum of 5 years of experience in quality assurance within the pharmaceutical industry, with a strong understanding of GMP, GLP, and GCP regulations.
• Proven track record of implementing quality systems, managing deviations, and driving continuous improvement initiatives.
• Excellent communication, problem-solving, and leadership skills.
• Experience with regulatory inspections and audits is highly desirable.
• Certification in Quality Management (e.g., Six Sigma, Lean, ASQ) is a plus.

• Opportunity to work in a dynamic and innovative pharmaceutical environment.
• Career growth and development opportunities.
• Collaborative and inclusive company culture focused on teamwork and excellence.

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