Global Pharmaceutical company, based in Little Island, Cork, IRL - looking for
Senior QA Specialist.
Duties & 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 4+ 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.
The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.
Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-
If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at or send your profile to -