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Senior QA Specialist

Reference ID : NHA52
Category :
  • Medical Devices
  • Science
  • Pharma / Biotech
  • General Manufacturing
Date Posted : Sep 3, 2018
Job Location
:
  • Leinster
- Dublin
Experience : 8+ Yrs
Salary : Neg
Employment Type
:
Contract
Consultant
:
Nicola O'Sullivan
Contact Number : 0870622429
Senior QA Specialist required for Dublin based biopharmaceutical multinational.

Principal Responsibilities

Senior QA Specialist

An opportunity has arisen for a Senior QA Specialist within a leading Dublin based pharmaceutical multinational

Key Duties:

• Provide Quality direction and input at Change Control and NC Review Boards and assume oversight of change control and NC/CAPA records. 
• Write, review and approve SOP’s. 
• Participate in site activities associated with QMS programs (e.g., Validation, Complaints, Change Control) and provide active input into shaping the future direction of these systems. 
• Review and approval of NCs and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable 
• Participates in customer complaint investigations. 

• Provide overall quality direction and oversight for key functional areas, Process Development, Validation, Quality Control, Supply Chain, Engineering, Information Systems, ensuring that programs, policies and procedures are robust and in keeping with regulatory and internal expectations. 
• Act as Quality point of contact and decision maker during Technology Transfer and Process Validation activities whilst ensuring that all activities meet internal and regulatory expectations. 
• Site Program Owners for site disposition activities, Quality Agreements, Site Master File, Market Action activities and for the provision of subject matter expertise for related programs including, Complaints, Stability and Product Quality Review. 


Qualifications & Requirements

Qualifications / Requirements:

• University degree. Engineering or Science related discipline preferred. 
• 8yrs + working in the pharmaceutical or biotechnology industry

• Experience working with dynamic cross-functional teams and proven abilities in decision making 
• Strong organizational and communication skills, including ability to follow assignments through to completion 
• Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations 
• Detailed Knowledge of applicable Regulatory requirements. Experience with Regulatory inspections. 
• Experience working in aseptic operations, protein formulation, vial and syringe filling.



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