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QUALITY ASSURANCE SPECIALIST - CONTRACT

 

Company:

PHARM ENG LTD
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Job Reference Number

14566176

Client ID:

RI/WS23E2YY22YYRYED
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Posted On:

Feb 6 2012

Location:

CORK
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Job Type:

Contract

Salary:

NEGOTIABLE
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PharmEng requires a QA Specialist on an hourly rate contract basis for one of our client sites based in Cork. The position will be for 6 months initially.

Job Description

  • Provides support and direction to all departments in respect of specific quality system
    elements to ensure business, quality and compliance goals are met
  • Partners with other Departments to ensure that compliance systems are implemented in an efficient manner. Carries out tasks (review and/or approval) related to the administration of site Change Control, Deviation and CAPA management systems
  • Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate. Supports system qualification and process validation activities:
  • Review and approval of qualification/validation documentation. Carries out duties related to Supplier Assessment, Auditing and Inspection Readiness Systems at the site:
  • Develops the raw materials and components specification and co-ordinates the pproval of these specifications via the global GPSG process.
  • Reviews and/or approves all completed batch records in accordance with site
    procedures

    Education / Experience
  • Bachelors Degree in a scientific/technical discipline required - A minimum of 2 years experience in a quality, validation or compliance role within - the biological and/or pharmaceutical industry. -
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics - and/or pharmaceuticals.
  • Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
  • Demonstrated knowledge and application of industry regulations as they apply to - validation, including those of FDA, IMB, EMEA and other authorities.
Please send in your CV for the attention of Robert Carroll.