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Quality Assurance Professional
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Cork, Cork, Ireland beBee Careers Full timeJob Summary:We are seeking a dedicated professional to support quality assurance activities across our facilities.This role plays a critical part in ensuring compliance, process validation, and continuous improvement to maintain the highest standards of pharmaceutical production.Key Responsibilities:Ensure Compliance & Quality Excellence:Oversee key quality...
Senior Quality Assurance Professional
3 weeks ago
The Senior Quality Specialist plays a pivotal role in overseeing quality across Contract Manufacturing Quality Operations and Quality Management Systems. This includes handling Corrective and Preventive Actions (CAPA) and collaborating with Subject Matter Experts or Process Owners to enhance internal Quality Systems.
Responsibilities include reviewing batch release documentation from Contract Manufacturers, ensuring timely completion of releases in local systems and escalating any issues that may impact Endo. Additionally, the individual contributes to decision-making processes, developing options to solve moderate to complex issues affecting quality.
The Senior Quality Specialist also supports the implementation of best practices and recommendations for business or compliance improvements, aimed at enhancing products, processes, or services. Furthermore, they prepare and review controlled documents required for regulatory compliance.
Key Responsibilities:- Reviews batch release documentation from Contract Manufacturers
- Contributes to decision-making processes to solve quality issues
- Supports the implementation of best practices for business or compliance improvements
- Prepares and reviews controlled documents for regulatory compliance
The Senior Quality Specialist takes the lead in resolving investigations, deviations, and corrective actions, addressing quality issues with each Contract Manufacturer. They also lead individual systems and assist in managing Quality System functions for cGxP manufacturing and distribution activities from local and Third Party manufacturing facilities.
- Takes the lead in resolving investigations and corrective actions
- Leads individual systems and assists in managing Quality System functions
The Senior Quality Specialist participates in cross-functional teams to prepare for regulatory inspections, quality agreements, auditing, validation activities, and special projects.
