Senior Quality Assurance Associate

Employer
Proclinical Staffing
Location
Clare, Republic of Ireland, Shannon
Salary
Negotiable
Closing date
30 Sep 2020

View more

Discipline
Quality, QA / QC
Hours
Full Time
Contract Type
Permanent
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Proclinical have a unique chance for you to join one of the leading pharmaceutical companies in the world as a Senior Quality Assurance Associate in their Ireland office. This role is a chance to elevate the quality of the entire organisation.

Job Responsibilities

    Provide QA support and oversight to the Irish operations team ensuring compliance with EU, Irish and FDA GxP regulatory requirements QA review and approval of quality documentation generate in Irish operations e.g. including but not limited to Deviations, CAPAs, change controls and logbooks Support a "Quality on the floor" culture and facility walk rounds to maintain a high level of compliance and QA oversight by working closely together with operations Generate and prepare quality documents Support the preparation, execution and follow up on regulatory inspections. Perform (plan, execute, follow up) self-inspections in a timely manner as per plan Provide QA review for the eQMS system documents Aid in the management and proactively initiate and support continuous improvement of the Quality Management System. Deliver GxP compliance training to operational areas Ensure own KPI's, plans, targets and objectives are effectively tracked, monitored and achieved in accordance with timelines.

Skills and Requirements

    Experience of working within a GMP Sterile manufacturing environment Good knowledge of controlled processes and GMP requirements to a QMS Proficient in Microsoft Office and experience in database use and eQMS systems Good organisational and time management skills and able to demonstrate flexibility and adaptability. Knowledge of GCP and GMP with regards to QMS activies Good team player and must also be able to work alone Experience in Competent authority, Regulatory body inspections and audits.

We hope to hear from you soon.

At ProClinical we have one aim: to support life science companies in the many challenges they face while combatting unmet medical need worldwide.

Ageing populations, rare diseases, epidemics and the millions of patients without access to medication are just a few of the pressing issues that life science companies contend with. The industry is under increasing pressure to develop new and innovative ways to save and improve patients’ lives. 

ProClinical’s mission is to support their work by connecting life science companies with the highly skilled professionals they need to continue innovating. 

Internal recruitment and HR teams often struggle to continuously source skilled, experienced professionals to fill highly-specialised and niche roles. ProClinical combines a deep understanding of the industry with extensive candidate networks to provide both a technical and cultural fit for our life science partners.

 

Contact Us
  • Eldon House
  • Eldon Street
  • EC2M 7LS
  • United Kingdom
  • 0800 988 4437
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