Senior Pharmaceutical Quality Assurance Specialist

About the Role

Our client is actively seeking a seasoned and proactive Senior Pharmaceutical Quality Assurance Specialist to join their esteemed quality team. This fully remote role is integral to upholding the highest standards of quality and compliance across all pharmaceutical operations. You will play a pivotal role in developing, implementing, and maintaining robust quality management systems, ensuring adherence to regulatory requirements and internal procedures. This position offers a fantastic opportunity to leverage your expertise in quality assurance within a flexible, remote-first setting, contributing to the delivery of safe and effective pharmaceutical products from anywhere.

Key Responsibilities

• Develop, implement, and manage the company's Quality Management System (QMS) to ensure compliance with GMP, GDP, and other relevant regulations.
• Conduct internal audits and host regulatory inspections, ensuring all findings are addressed and corrective actions are implemented effectively.
• Review and approve critical quality documents, including batch records, validation protocols, and change control requests.
• Investigate deviations, out-of-specification (OOS) results, and customer complaints, determining root causes and implementing CAPAs.
• Provide quality oversight for manufacturing processes, validation activities, and supplier qualification programs.
• Train personnel on quality assurance principles and procedures, fostering a quality-centric culture throughout the organization.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related Life Science discipline.
• Minimum of 7 years of experience in Quality Assurance within the pharmaceutical industry.
• Extensive knowledge of Good Manufacturing Practices (GMP) and regulatory guidelines (e.g., MHRA, FDA).
• Demonstrated experience in audit management, deviation investigations, and CAPA implementation.
• Excellent analytical, problem-solving, and decision-making skills.
• Proficiency in quality management software and tools; experience with remote collaboration platforms is essential.

Benefits

• Highly competitive salary and potential for annual bonuses.
• Comprehensive health, dental, and vision insurance.
• Flexible working hours and a fully remote work environment.
• Generous annual leave and company holidays.
• Opportunities for career advancement and continuous professional development.