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.
Requirements:
Key Skills and Competencies Required:
* Ability to Build 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.
* Third level Degree in a science or pharmaceutical discipline.
* A minimum of 3 years of experience within the Pharmaceutical Industry.
* Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.