Functional Quality Specialist I

The responsibility of this role is to provide all clients, both internal and external, with high-quality service in a safe and cost-effective manner. You are expected to adhere to legal requirements such as the Health and Safety at Work Act 1974, COSHH regulations 1989, and EC Directives 1992/3 as outlined in the Company's Health and Safety Manual. Your key responsibilities include: - Conducting quality reviews of assigned cases. - Compiling quality metrics based on reviews and identifying trends. - Assisting in client quality reviews and preparing corrective and preventive actions. - Ensuring implementation of CAPA results in coordination with project managers. - Reviewing various cases and safety reports for regulatory submissions and labeling documents. - Managing adverse events, product quality complaints, and medical information to meet timelines. - Participating in process reviews, designing training schedules, and contributing to process improvements. - Coordinating audits, developing Quality Management Plans, and supporting regulatory inspections. - Analyzing data, suggesting process improvement strategies, and responding to queries. - Executing drug safety data management processes and guiding safety associates. - Supporting sponsor during regulatory inspections or audits and responding to safety reports. Qualifications required for this role: - Bachelor's/Master's/PhD degree in relevant fields or equivalent experience. - Minimum of two years of experience in pharmacovigilance/safety writing. - Proficiency in medical and drug terminology, GCP, GVP requirements, ICH Guidelines, and regulatory requirements. - Technical proficiency with Microsoft Office applications. Preferred qualifications: - Experience in generating quality metrics, trend analysis, and coordinating corrective actions. - Knowledge of Medical Device reporting is desirable. Physical Demands/Work Environment: - Office environment with occasional travel required. This role offers an opportunity to contribute to quality operations, process improvements, and regulatory compliance in the pharmaceutical industry.,