Job Description
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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