Junior Qualified Person

  • Permanent
  • Location: Offaly
  • Ref: 917432

Job Details

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What you need to know

Matrix Recruitment Group are currently recruiting for a Site Compliance and Product Release Senior Specialist / Qualified Person for our client in the Pharmaceutical industry based in Offaly.

Your new job

  • Support the implementation & continuous improvement of an effective quality management system including quality oversight across the site
  • Assume an active role in the creation, modification and maintenance of the Quality Management Systems supporting operational and release functions
  • Review & approval of batch records and associated raw data for manufacturing operations to ensure compliance with the requirements of cGMP and batch review and batch disposition process
  • Participate in and support Site License registration process and future license updates
  • Review of analytical data and associated reports
  • Review and approval of non-conformance events and reports including deviations, laboratory investigations & environmental excursions
  • Perform batch review and approval of investigational veterinary products and commercial products
  • Participate in or lead internal and external audit including 3rd party audits and supplier reviews
  • Interface with other departments such as Engineering, Laboratories, Operations, Warehouse and Process Development to ensure quality objectives are understood and achieved
  • Initiate and implement change control activities in accordance with site procedures
  • Assist with oversight of issue management and non-conformance events to ensure compliance and timely closure
  • Maintains a contemporary understanding of cGMP regulations and guidance in relation to all aspects of validation across manufacturing, laboratories and facilities
  • Partake in or lead periodic quality review meetings to ensure compliance and continuous improvement
  • Write or assist in writing, reviewing and approval of SOPs and other GMP documents
  • Develop and where appropriate deliver training across the teams regarding the quality topics and metrics

What are we looking for?

  • BSc, MSC in a relevant discipline (e.g biochemistry, chemistry, process engineering) and be QP qualified.
  • At least 5-7 years relevant experience in a Pharma (Sterile) /BioPharma Manufacturing environment.
  • Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.
  • Experience of interaction with cross functional departments.
  • Good knowledge of regulatory and cGMP guidelines and directives, including product certification, validation, quality control and manufacture including QbD and Risk Management.
  • Ability to support relevant sections of CTD for regulatory submission.
  • Excellent interpersonal and communication skills, meticulous eye for detail.
  • Self-motivation.

    Apply for this job now via the link below

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    Recruitment Consultant: Joanne Foley

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