2021-06-30 14:28:192048-11-13Team Horizon
Job TypeContractor
SectorQualityOperations & Manufacturing
Start Date
AdvertiserAshling Guthrie
Job Ref#2104
Job Views439
We have an exciting opening for a Qualified Person at our client’s state of the art aseptic manufacturing facility in Dublin. In this role you will be responsible for ensuring each batch of medicinal products has been manufactured and checked in compliance with the requirements of Commission Directive 91/356/EEC of 13 June 1991 laying down the principles and guidelines of good manufacturing practice for medicinal products for human use.
Why you should apply:
  • Join a progressive company with state of the art working facilities, which include an onsite gym and flexible working conditions such as flex hours and WFH
  • There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
What you will be doing:
  • Own, review and approve SOP’s and other GDP/GMP documentation and records, ensuring that Corporate, Site and Regulatory requirements are met.
  • Perform review and approval of validation documentation.
  • Lead and participate in internal and external audits as needed.
  • Maintain a close contact and familiarity with Quality systems and programs utilized at other company sites.
  • Provide guidance and direction to Quality, Production, Warehouse/ Distribution and Supply Chain staff in regard to compliance with quality policies, standards and procedures.
  • Evaluates and assess change control records, nonconformances and CAPAs.
  • Participate in global Quality initiatives as a site subject matter expert.
  • Participate or lead projects and improvement efforts including product launches.
  • Supports the evaluation of quality and distribution complaints.
  • Supports regulatory inspections or various questions from regulatory bodies.
  • Perform activities as required per company procedures as QA staff, and in particular where the role of QP is specified in the procedures.
What you need to apply:
  • University Degree in Pharmacy or University Degree in a Science related discipline together with a post graduate course, which together with the primary qualification, satisfies the educational requirements as defined in Directive 2001/83/EC
  • Knowledge of the processes involved in manufacturing (GMP), warehousing, supply chain, equipment engineering
  • Relevant Experience working in the pharmaceutical or Biotechnology Industry over a minimum of 2 years
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