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Quality Assurance Associate

I7817

QA Associate required for client side position with West Dublin based Pharmaceutical client

Category:
Quality
Location:
Leinster
Years of Experience Req.:
2+ years
Date Posted:
31/10/2019
Days Remaining:
7
Employment Type:
Contract
Education Level Req.:
See Description

QA Associate

Role Responsibilities:

  • Coordinate and execution of batch record review
  • Coordinate and execution of area clearance record review
  • Assisting in, and facilitating, investigations as part of the site Deviation Management System, ensuring effective root cause analysis and assigning of appropriate CAPAs.
  • Support activities relating to the Quality Management System (QMS), which include, but not limited to; CAPAs, change control, material and service supplier management.
  • Assist and co-ordinate the preparation of reports in relation to Annual Product Reviews for products manufactured on site.
  • Participate in the on-site GMP Inspection schedule
  • Participate in the internal audit schedule.
  • Support the Environmental monitoring programme 
  • Develop SOP & other GMP Controlled Documents.
  • Review of master records.
  • Support activities relating to customer complaints, product returns and product recall
  • Support the onsite audit team during external cGMP audits, e.g. from Regulatory Authorities and Global Quality.
  • To actively support the development/implementation of continuous improvement activities.
  • Participate in other projects as directed by the Quality Assurance Executive.
  • Actively support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas.
  • Support and review process simulations (Media Fill). 

Role Requirements:

  • Bachelor's degree in chemistry, biology or a related scientific discipline
  • Experience in quality in the pharmaceutical industry.
  • Experience working in cell culture/ finished product pharmaceuticals/ biologics, including biochemistry, microbiology, quality assurance, quality control, development, and/or manufacturing areas.
  • Understanding of quality and cGMP's
  • Excellent verbal and written communication skills.
  • Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
  • Work directly with other key departments to ensure compliance and productive working relationships.

 

DPS is an Equal Opportunities Employer.

Recruitment Agencies: Please do not reply to this job advert.

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