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Q.A. MANAGER

 

Company:

RFT GROUP
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Job Reference Number

14572054

Client ID:

RI/
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Posted On:

Feb 22 2012

Location:

DUBLIN
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Job Type:

Permanent

Salary:

NEGOTIABLE
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Benefits:
  • TRAINING / EDUCATION
  • MOBILE PHONE
  • BONUS
  • PERM. HEALTH INSURANCE
  • LIFE ASSURANCE
  • PAID HOLIDAYS
Q.A. Manager



Our client is a Dublin based fast expanding pharmaceutical company. Continued rapid growth has led to the need for a newly created role : Q.A. Manager.

Job Spec :

Reporting to the Director of Quality this individual will be responsible for performing key Quality tasks in respect of Company systems, products and development projects. Specifically the individual will review IT systems and equipment qualification in CMO for the Quality Group, within the Technical Operations department. They can also be involved or oversee contract manufacturing operations, select supply chain operations and development functions as well as internal Quality Systems.

Responsibilities :

The individual will be responsible for developing and maintaining Quality Systems activities to ensure that all operations are fully in compliance with current international standards for cGMP.

The individual may be responsible for, but is not limited to:

  • Reviewing validation protocols and reports to include
    • Computer system/software validation
    • Method validation
    • Cleaning validation
    • Process validation
  • Managing the product stability programme
  • Investigating out-of-specification (OOS) reports
  • Conduct of vendor audits and vendor site visits as required
  • Conduct of internal audits and/or co-ordinating audit programme
  • Operating the Deviation & CAPA system
  • Developing and reporting Quality Metrics
  • Operation and maintenance of the Documentation system including SOPs and Change Control.
  • Supporting the product complaints system
  • Supporting regulatory submissions
  • Review and approval of product artwork
  • Assisting in preparation of Annual Product Reviews
  • Supporting development projects
Person Spec:



  • Bachelor’s degree in chemistry, biology or a related discipline
  • Significant experience working in finished product pharmaceutical / biologics, including analytical chemistry, quality assurance, quality control, development, and /or manufacturing areas.
  • Experience with third party vendor auditing, out of spec investigations, change control.
  • Experience with the following desirable:
    • Computer system/software validation
    • Analytical chemistry including method validation
    • Third party drug product manufacturer audits
  • Thorough understanding of quality systems and cGMPs.
  • Interpersonal skills and professional skills to interact at all levels including senior executives, contractors, and colleagues.
  • A true self starter, who works effectively on their own initiative, and is used to working in demanding environments where there is continuous change and ambiguity
  • Some travel (up to 25%) may be requiredExperience working with contract manufacturing
  • Experience interfacing with regulatory bodies or working on regulatory submissions
  • Highly organised, with exceptional time management and prioritisation
  • Strong work ethic
CV to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie