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.
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