Hybrid but required to be flexible in this regard
Need experience in sterile or aseptic environment - min 3 years but ideally more
Supervisor – Quality Assurance Team Lead.
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 demonstrate Integrity and Credo-based actions.
-Ability to work independently, manage their own time and
meet deadlines as appropriate.
Education and Experience:
-Third level Degree in a science or pharmaceutical
discipline.
-A minimum of 3 years of experience within the
Pharmaceutical Industry.
-A working knowledge of quality processes and systems
is desirable.
-Demonstrated knowledge and application of industry
regulations including those of FDA, HPRA, EMEA and
other authorities.