Duties and Responsibilities
- Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
- Quality review and approval of Master Batch Record(MBR) record for routine cleaning and process activities, including Automation recipe updates.
- QA Review and Approval of SOPs, Work Instructions and forms from other departments.
- Attendance at Daily/Weekly Operations led Team Meetings.
- Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.
- QA review and approval of Warehouse Shipping Picklist.
- Primary QA point of contact for Quarantine Shipments.
- Responsible for Batch Book Filing & Archival.
- QA review and approval of quality non-conformance
- (NC) records and customer complaint non-conformance records.
- Initiation and ownership of QA non-conformance records.
- Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
- Primary Quality point of contact for attendance at Root Cause Analysis meetings.
- Primary QA point of contact for the Returns process.
Minimum Requirements
Key Skills and Competencies Required
- Builds strong, productive relationships
- Demonstrates ability to work with teams and individuals
- Seeks opportunities to grow and develop professionally
- Uses best practices to improve business operations
- Holds self-accountable for compliant and flawless execution
- Takes personal responsibility for decisions that successfully build customer value
- Effectively manages and adapts to change
- Always demonstrates integrity and Credo-based actions
- Ability to work independently, manage own time, and meet deadlines as appropriate
Education and Experience
- Third-level degree in a science or pharmaceutical discipline
- Minimum of 3 years of experience within the pharmaceutical industry
- Working knowledge of quality processes and systems (desirable)
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
