QA Specialist – Biotech (Pfizer)

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Job Description

Introduction:

Responsibility for tasks pertaining to compliance and product quality. The QA specialist will partner with relevant dept to ensure key systems/metrics are operated and maintained in a compliant manner

Job Purpose: 
Providing Quality oversight for Tech Transfer Projects to ensure compliance with regulatory and cGMP requirements during the design, qualification and operational readiness phases for a number of site critical projects. This role is required to partner with relevant departments to ensure that key quality systems are operated and maintained in a compliant manner. 

Job Responsibilities: 
• To provide consultative support on quality related issues to project teams. 
• Participate in cross-functional teams as required. 
• Ensuring all production steps have been performed and verified, that all limits and specifications have been met. 
• QA support for qualification activities - review and approve equipment/utility qualification documentation from design to post execution. 
• Review / approval of technology documentation. 
• Review/approval of production instructional documentation (SOPs and batch records) to ensure they are up to date, compliant, and support efficient production, 
• Carryout cGMP compliance area walk-throughs of Manufacturing Operations as required. 
• Participate in the internal audit programme as required. 
• Maintain tracking system for project document review status. 
• Review event/investigation reporting including support of Manufacturing Operation teams with investigations and resolution of discrepancies. 
• Co-ordinate and review change controls as required. 
• Perform completion of batch disposition packs within required timelines /Work with site QPs to ensure timely issue resolution to final disposition. 
• Review of regulatory documentation 
• Assist in the creation and maintenance of up to date QA policies, SOP’s and reports. 
• Assist in the development of training curricula and records for the QA Operations Group. 
• Perform and assist with additional duties as may be directed by the QA Ops Lead. 

Education/Experience 
• BSc degree in biology, chemistry, or other related technical degree. 
• Min 4 years working experience in a pharmaceutical manufacturing environment, preferably in a quality assurance or quality control role. 
• Previous QC/QA and/or pharmaceutical experience in a GMP or GLP facility. 
• Excellent communication and interpersonal skills. 
• An ability to work independently, as well as a member of a team in a dynamic, fast-paced environment.

Please contact me (Eamonn) on; 01 614 6069 or, email on eamonn.errity@cpl.ie to discuss further.

Apply via LinkedIn

Eamonn Errity

Talent Partner +353 1 6146000 Eamonn.errity@cpl.ie
  • Salary:Negotiable
  • Location:West Dublin
  • Type:Contract
  • Category:Science
  • Ref.no:JO-1707-357954_50