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Senior QAV Engineer

  1. NI & Ireland
Dublin 16
  1. Contract
Competitive
  1. Compliance / Quality Assurance
04-03-2021
26326 JL

This vacancy has now expired

Experienced Quality Assurance Validation Engineer/ Specialist required by a world leading biotechnology company in Dublin to support the introduction of multiple products (NPI) at their state of the art manufacturing facility.

 Responsible for ensuring ensure products are introduced and manufactured in accordance with cGMP, Corporate and Regulatory requirements, this is a key role on an initial 12 month contract with scope to extend long term. 


The Role 
  • Quality Oversight on new product and equipment introduction into the facility.
  • Site QA responsibility to provide technical expertise for all QA and compliance topics / issues relating to the facility. 
  • Quality oversight on validation activities in project workstreams involving cross-functional, multi-departmental teams including: Operations, Process Engineering, Quality Control, Quality Assurance, Facilities, and others.
  • Support quality oversight of validation activities through the review and approval of validation documents for equipment, software and equipment qualifications, and others.
  • Review / Approval of Validation Protocols and Reports (e.g. URS, Facility, Utility, IT Systems, Test Method, and Equipment validations) to ensure compliance with current regulatory expectations, EU, FDA and Corporate Standards and Internal Procedures.
  • Quality oversight on operations and technical services to review and approve Process descriptions , sampling plans, operational procedures, Master production batch records  process validation and cleaning validation documents .
  • Investigation and approval of deviations generated encountered during qualification/validation testing.
  • Participation in the change control program and deviations for modifications to new and existing equipment.
  • Implement, deploy and revise as applicable Quality Validation procedures.
  • Provide guidance to project teams on Quality regulations for Validation strategy and approach.
  • Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk
  • Ensures schedules for review and approval of GMP documents are maintained to meet the needs of Commercial Operations groups.
  • Provide sound QA and Compliance support to manufacturing, QC, engineering, utilities, supply chain and material movement.
  • Provide support for deviation investigations, including root cause analysis, and corrective & preventative action (CAPAs) proposals and initiatives.
  • Actively support audit readiness activities and regulatory agency and internal audits.
  • Actively contributes to continuous improvement activities.
 
 
 Required
  • A minimum of 5 years relevant experience within the pharmaceutical industry or a related field.
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing and/or packaging required.
  • Direct experience of GMP management within a pharmaceutical/bio pharmaceutical company is essential, and will include exposure to FDA, HPRA/EMA or other authorities of similar standing. 
  • Excellent accuracy and attention to detail
  • Good knowledge of relevant computer packages e.g. TrackWise or similar
  • Planning and organizing skills are required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
  • Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.
  • The individual in this position is expected to represent the clients' Pharmaceutical interests, objectives and policies in a responsible and professional manner.       
  • Experience of sterility assurance for drug products and in manufacturing processes for pharmaceutical products and processes strongly desirable.
  • Third level qualification e.g. B.Sc. in science/pharmacy with a minimum of 5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience. 
 



  Please apply now with your CV highlighting your experience in QA assurance on equipment or NPI projects.



The candidate must have the rights to work in the location stated in the job advert.

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