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.