What are the responsibilities and job description for the Quality Assurance Manager position at Catalent Pharma Solutions?
Overview
Catalent Pharma Solutions is a global leader in the development and manufacturing of new treatments for patients worldwide. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of quality and compliance across our operations.
About the Role
We are seeking an experienced Quality Assurance Manager to lead our quality systems audit function. In this role, you will be responsible for managing the core quality systems, including investigation/deviation management, CAPA tracking, change control, risk management, and quality metric tracking.
Key Responsibilities
- Manage the QA staff supporting Investigation/Deviation/CAPA Management, Change Control, Risk Management, Quality Metric Tracking responsibilities;
- Ensure staff are fully trained on all cGMP manufacturing operations and documentation and adhering to safety guidelines;
- Oversee daily activity for the group to ensure quality results Performance management for direct reports;
- Responsible for and administers Investigation and Deviation systems for tracking statuses, follow-up, and liaison with applicable department investigation writers to ensure their complete and timely resolution;
- Responsible for and administers the CAPA Tracking System for general GMP use and internal audits. Track the timely completion and extension of commitments;
- Perform trending review of deviations and investigations, compile report and identify trends or areas requiring additional actions;
- Responsible for and administers the change control system for tracking and coordinating the initiation, execution and completion of change controls;
- Responsible for and administers the Risk management system and track completion of risk assessments;
- Compile pertinent QA metrics for Senior Management review; assemble critical metrics from applicable departments, analyze using appropriate tools to identify trends and report via a PowerPoint presentation to be reviewed by Senior Management on a periodic basis. Track action items for completion;
- Support client projects and provide quality oversight of manufacturing operations and the release of drug substance and/or final drug product to support Phase I/II clinical trials; potential work with clients during initial and subsequent manufacturing campaigns; supports regulatory (FDA, EMA) and client audits/inspections of Catalent; assists with performing internal audits;
- Maintains databases and systems used for tracking various GMP manufacturing associated support activities; assists with the generation and/or revision of GMP documentation such as standard operating procedures; continually evaluates systems and procedures for improvement for efficiency while ensuring compliance to applicable regulatory requirements and standards;
- Works closely with manufacturing, Facilities and Quality Control staff to resolve quality issues with regard to the facilities and product manufactured; works closely with other departments at Catalent and offer assistance as needed;
- Proactively partners with Human Resources to attract and retain top talent and takes an active role in ensuring new employee onboarding is a success.
