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QA SPECIALIST (12 MTHS)

 

Company:

FASTNET RECRUITMENT
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Job Reference Number

14566695

Client ID:

RI/QAC1MER
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Posted On:

Feb 8 2012

Location:

CORK
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Job Type:

Contract

Salary:

NEGOTIABLE
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Benefits:
  • PENSION / PRSA
  • BONUS
  • PERM. HEALTH INSURANCE
  • PAID HOLIDAYS
We are currently recruiting an experienced QA Specialist for a 12 month contract role with a pharmaceutical client, based on site in their chemical API manufacturing facility in Cork.

Specific Responsibilities will include:

  • Ensuring compliance to new and established systems and global regulations and guidelines for a wide range of complex active pharmaceutical ingredients and drug substances
  • Implementation and maintenance of all site Quality/Compliance Systems
  • Working as part of a team with an emphasis on continual improvement of processes, quality management systems and compliance.
  • Preparation of SOP’s and carrying out document review/updating as appropriate
  • Manage the Deviation, Out of Specifications and Change Control systems.
  • Participate in cross functional investigations of deviations, out of specifications and change controls. Advise on corrective actions and assist with their implementation.
  • Participate in cross functional teams for the introduction of new products/processes, carrying out risk assessment and preparation/approval of cleaning documentation associated with these activities
  • Ensure all site calibrations and PM programmes are carried out in a compliant manner and within agreed schedules
  • Preparation of the site for audits by Regulatory Authorities and Customers
  • Participate in all aspects of audits by Regulatory Authorities and Customers
  • Conduct internal audits as per agreed schedules.


Requirements include:

  • BSc Degree in a technical or scientific based subject - Chemistry/Biochemistry or equivalent
  • A minimum of 3 years experience in an IMB/FDA regulated manufacturing company in a Quality Assurance or Compliance role
  • Competent and knowledgeable of all relevant ICH guidelines, particularly ICH Q7A, EU GMP guide annex 18, and all FDA requirements relating to 21 CFR 210 and 21 CFR 211
  • Excellent communications skills
  • Flexibility is essential
  • Proven ability to work on own initiative and to strict deadlines with minimal supervision
  • Excellent PC skills MS Word, Excel, PowerPoint, etc


If this position is of interest, please forward your CV to Fastnet Recruitment or telephone Éimhín Russell for a confidential discussion at 021 4509200. eimhin@fastnetrecruitment.com

Fastnet Recruitment has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet Recruitment
'Not Just Placers.........Partners'

http://www.fastnetrecruitment.com/

The Pharmaceutical Recruitment Specialists