Senior Manager & Qualified Person

2022-04-27 16:25:132049-09-25Team Horizon
Job TypePermanent
LocationWestport, Mayo
AreaMayoMayoIrelandWestport, Mayo
Start Date
AdvertiserDarcy Ainscough-Denton
Telephone+353 1 574 6266
Job Ref2442
Job Views114
Senior Manager & Qualified Person – Team Horizon
We are currently recruiting a Senior Manager & Qualified Person to join the Eyecare Quality team for our client, a Global Biopharmaceutical company with a facility in Westport, Mayo. In this role, you will be responsible for the integration and support of quality regulations: Ophthalmic drug, device and combination products. Products for their Eyecare Business driving the design of effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout their quality systems. You will also develop and implement sound quality principles while minimizing disruptions to business, based on robust quality risk assessments.
Why you should apply:
  • Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
  • The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
  • Excellent career progression opportunities.
What you will bedoing:
  • Perform the disposition of drug, combination, and device products. Ensure batch disposition process is compliance with company practices and regulatory requirements.
  • Support and endorse the non-conformance, change management and complaints programs at site
  • Provide quality direction and guidance for projects related to processes, equipment, product, and compliance
  • Represent quality unit at business unit, project, and compliance meetings
  • Provide input and approval of quality management system, procedures, validation, release, and compliance documents
  • Responsible for the management and oversight of a team, as applicable, including hiring, setting performance expectations, providing performance feedback, development of staff and handling of personnel issues.
  • Ensuring adequate resources and appropriate training to effectively support and meet changing business and compliance needs.
  • Establish training requirements and maintenance of a diverse and agile cross trained and effective team to ensure business continuity and compliance.
  • Lead and oversee support activities related to product actions
  • Assure key metrics are being monitored and met to ensure compliance and to drive continuous improvement including review of procedures and process to identify areas of opportunity
  • Partner with stakeholders across the enterprise to gain a better understanding of processes to determine best steps forward
  • Perform assessments to determine compliance to processes, procedures, and regulations to identify potential gaps and mitigate and implement improvements.
  • Support internal and external quality inspections and audits including reporting, response to observations and tracking of action plans.
  • Represent FQA in regional, global and cross functional teams, projects and programs, as appropriate.
What you need to apply:
  • Bachelor’s Degree in Chemistry, Pharmacy, Biology or other technical/scientific area required
  • Qualification in Pharmaceutical Manufacturing Technology or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC
  • Eligible to act as Qualified Person to perform release of medicinal and investigational product
  • 2-4 years’ experience in quality assurance, operations, regulatory or relevant experience. Some supervisory/management experience preferred
  • Knowledge of aseptic processing, sterilization and packaging processes is desirable but not essential
  • Knowledge and familiarity with product, process, and both internal and external customer requirements and regulations
  • Knowledge of QA systems and GxP compliance requirements including regulations and standards affecting pharmaceutical products, combination products and devices
  • Strong influencing, motivational, interpersonal and relationship building skills at all levels.
  • Excellent written and oral communication skills. Proficiency in English.
  • Ability to think strategically and enterprise wide to ensure compliance and business needs are met or exceeded
  • Strong decision-making skills
  • Negotiation skills, effective collaboration, and ability to anticipate needs and requirements
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