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QAV/ CQV Quality Specialist

  1. NI & Ireland
  1. Contract
Competitive
23696-ML
  1. Commisions, Qualification and Validation
Date Posted25 Oct 2019
Do you want to be part of one of the top 10 best companies to work for in Ireland? If so, this could be your chance! One of our global pharmaceutical clients is looking for QAV Engineer to join their team in Dublin for their new large-scale facility.

This is a fantastic opportunity to be part of a fast-paced, €700 million project; with lots of opportunities to work with and learn about cutting-edge technologies, in addition to developing your own skills.  

This is a truly exciting project, which when complete will contribute to the manufacturing of a life changing treatment.

Essential Duties and Responsibilities for this QAV role include,
  • Support quality aspects of qualification and validation of equipment, facilities, and utilities associated with Manufacturing to ensure compliance with company policies, procedures and regulatory expectations. 
  • Will serve as the Quality SME for all validation activities across the site including but not limited to: Utility and equipment performance qualification, Steam in Place(SIP) & Cleaning Validation.
  • Provide Quality oversight for Temperature mapping studies across Site Controlled Temperature Units (CTU’s). For example, standalone CTUs, Warehouse temperature controlled storage, Site Stability rooms.
  • Support Validation of cleaning (CIP) cycles/methods/recipes for buffer and media preparation systems, upstream (bioreactors) and downstream equipment trains, parts washers and supporting process equipment.
  • Input to Standard Operating Procedures (SOPs) and Work Instructions (WI) to enable suitable cleaning sampling activities to occur.
  • Serve as a quality resource for assessing validation requirements, non-conformance, impact assessments, root cause analysis and implementation of CAPA found during CQV activities.
  • Work closely with stakeholders and SME’s from site operations, quality operations, engineering & MS&T to provide quality oversight throughout the qualification and validation lifecycle.
  • Support sustaining activities such as Change Management, Periodic review, Requalification, Site Cablibration Program
  • Use of Quality Risk Management and Operational Excellence to promote continuous improvement.
Desirable Experience:

General
  • This role requires a minimum of 3 years experience in, Quality Assurance,Technical Operations or Engineering within the Biopharma / Pharmceutical industry. 
  • A self-starter and results-focussed, the successful candidate will have strong contemporary knowledge of relevant cGMPs, regulations and current industry trends.
Technical
  • Experience working in regulated environment with exposure in the Regulations & guidance’s – GMP, CGMP, GAMP, 21 CFR Part 11
  • Must have at least 3 years of experience in commissioning, qualification, and validation activities in in a regulated environment.
  • Technical knowledge of Cleaning validation/verification, quality systems and regulatory requirements.
  • Experience in review and approval of Cleaning Validation studies.
  • Experience in review of temperature mapping studies. Ex CTU’s, Autoclaves, SIP systems.







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