Senior QA Associate

Overview:
Assist the Quality Compliance Manager and QA team in implementing and maintaining the quality management system (QMS) at the site and with external partners.

Key Responsibilities:

• Manage and track CAPA, deviations, and change control processes.
• Address and resolve supplier and customer complaints in a timely manner.
• Conduct root cause analysis (RCA) and quality risk management (QRM) activities.
• Collaborate with global teams to ensure consistency across quality systems.
• Deliver QMS training and maintain up-to-date records.
• Analyse QMS metrics and prepare reports for management reviews.
• Support internal and external audits, ensuring compliance with standards.
• Facilitate vendor onboarding and maintain vendor compliance.
• Review and update QMS processes, ensuring they align with industry best practices.
• Investigate and close complaints within regulatory timelines.
• Support the creation of technical agreements and quality assessments.
• Ensure regulatory inspections and audits are properly documented and supported.
• Drive improvements in the QMS to enhance operational efficiency.
• Lead quality event resolution, ensuring timely closure of issues.
• Maintain and develop SOPs and training materials to ensure quality compliance.

Required Skills & Experience:

• Strong knowledge of GMP, GACP, and GDP.
• Excellent communication and interpersonal skills.
• Proficient with IT tools and quality management systems.
• Significant experience in quality assurance within pharmaceuticals or biotech.
• Bachelor’s degree in a related scientific field; advanced qualifications preferred.