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Senior Specialist Quality Systems - Ireland  

Company managed [?] Still accepting applications

Posted on : 23 May 2017

Project Description

Position Summary
  • A key member of the team responsible for delivery of quality systems oversight for activities at our company to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.
  • This key role must ensure effective interaction and partnering with other departments and locations regarding the operation of key Quality Management Systems and overall compliance.

 

Principal Responsibilities:
Areas of responsibilities shall include, but are not limited to:
  • A key member of the team responsible for delivery of quality systems oversight for activities at our company to ensure commercial and/or clinical products are manufactured and distributed in accordance with all regulatory and corporate requirements.
  • The coordination and management of the following Quality System elements such as Deviations, CAPA and Change Control, Vendor Quality Management, Quality Risk Management, Annual Product Quality Reviews, Quality Management Review, Quality Council, Product Quality escalations and Self Inspection.
  • This key role must ensure effective interaction and partnering with other departments and locations regarding the operation of key Quality Management Systems and overall compliance and will be assigned across the team of Senior Specialists to ensure optimal balance.
  • To act as designee for the department manager in their absence.
  • Performs timely review of documentation/investigations/reports highlighting and assisting in the resolution of issues commensurate with the level of risk and ensure schedules for review and approval of GMP documents and other key system outputs are maintained to meet the needs of Clinical and Commercial Operations groups for all key projects.
  • Provide sound QA and Compliance support to manufacturing, quality control, engineering, utilities, supply chain and material movement (including cold chain) for both clinical and commercial products.
  • Identification and active participation in the resolution of potential problems through Continuous Improvement initiatives prior to their having an adverse effect on the established business.



Profile:
  • A minimum of  8-10 years relevant experience within the pharma industry or a related field.
  • Strong knowledge of cGMP requirements for pharmaceutical manufacturing, quality control  required.
  • Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing. 
  • Excellent accuracy and attention to detail
  • Good knowledge of relevant computer packages e.g. Trackwise or similar
  • Planning and organizing skills required to plan, execute and track commitments of Quality Assurance and to adjust to changing priorities.
  • High level technical skills including analytical, auditing, pharmaceutical manufacturing and regulatory inspection management. Technical writing skills required.
  • Excellent interpersonal skills and the ability to communicate well, both verbally and written.
  • Proven ability to develop, propose and influence system change.
  • As this role is external facing across APIT function and the wider organization the individual is required to show natural leadership skill of collaboration, leading and directing activities of others towards a defined end goal.

 

Education
  • Third level qualification e.g. B.Sc . in science/pharmacy with a minimum of  5 years’ experience in cGMP Quality environment; or equivalent combination of education and experience.
  • Supervisory experience preferred.
  • QC experience and Qualified Person eligibility is desirable but not essential. 
  • Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous).     

 


About Us: 
  • Our company is a global biopharmaceutical company focused on developing and delivering life-transforming therapies for patients with devastating and rare disorders. Our company  developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS), two life-threatening ultra-rare disorders.  
  • As the global leader in complement inhibition, our company  is strengthening and broadening its portfolio of complement inhibitors, including evaluating potential indications for eculizumab in additional severe and ultra-rare disorders.  
  • Our company's metabolic franchise includes two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare disorders 
  •  In addition, our company is advancing the most robust rare disease pipeline in the biotech industry, with highly innovative product candidates in multiple therapeutic areas.