Qa Specialist

Description:

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.
   

Job 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