QA Specialist - Senior

A Senior QA Specialist –is required by CareerWise Recruitment to join our based Cork based pharma manufacturing client - Need experience in sterile or aseptic environment.  12-month initial contract role.

ROLE

* 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:

* Third level Degree in a science or pharmaceutical

discipline.

* 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,

Please call Diarmuid Buckley today for further information on 021- 4355432 or email: dbuckley@careerwise.ie

CareerWise Recruitment (In Search of Excellence)

Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. 

We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.

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