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QP / QA Manager – External Manufacturing

Contract Type: Permanent
Location: Unknown
Contact Name: Laurentina Kennedy
Contact Email: laurentina@rftgroup.ie

Job Description

QP & QA Manager – External Manufacturing
The Qualified Person & QA Manager – External Manufacturing will ensure that the highest standards of Quality Operations (QA & QC) are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.
The role will include the formalised release and certification activities within the UK, EEA & other relevant markets

Main Responsibilities
  • Deploy and maintain GxP Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
  • Deploy and maintain a Quality Auditing capability with the use of CAPAs to identify and track required improvements.
  • Ensure that critical quality issues are reported to company management using the Global Quality alert process.
  • Review and sign-off of master production, process validation and cleaning validation documentation provided by CMOs.
  • Carry out the disposition of Finished Products, APIs, Raw Materials and Components
  • when required.
  • With the Director of Quality and Director of Relationship Management, develop a quality strategy aligned with the overall business strategy
  • Reduce and mitigate product risks
  • Develop opportunities for improvement
  • Identify risks associated with products and systems
  • Appropriately remediate and mitigate risks associated with systems & products
  • Identify and implement opportunities to simplify EMO business processes including sampling, testing and data generation.
  • Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.
  • Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing.
  • Assuring that the batch has been manufactured and checked in accordance with the requirements of its MA.
  • Assuring the batch has been manufactured and checked in accordance with the principles and guidelines of GMP & any other legal requirements.
  • Product Certification & Release in accordance with 2001/83/EC (as amended) and 2001/82/EC (as amended)

Experience & Qualifications:
BSc a life sciences discipline, chemistry or biochemical engineering. Eligible to act as a Qualified Person as defined in 2001/83/EC (amended) and 2001/82/EC (amended). With 5 years of hands-on experience gained in both Quality Assurance and Quality Control departments.
MSc in a Life Sciences discipline. 7 years of hands-on experience gained in both Quality Assurance and Quality Control departments with at least 3 years in a Supervisory position. 3+ years as an active Qualified Person named on an MIA.

For further information on this QP & QA Manager position please contact Laurentina Kennedy at The RFT Group on 01 2302400 / Laurentina@rftgroup.ie. Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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