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QUALITY VALIDATION DOC SPECIALIST

 

Company:

HORIZON WEST

Job Reference Number

14575140

Client ID:

RI/JR2502032012

Posted On:

Mar 2 2012

Location:

CONNAUGHT, MAYO

Job Type:

Permanent

Salary:

NEGOTIABLE

If you’re a highly motivated Documentation Specialist looking to gain hands-on experience with a leading knowledge provider then this is an excellent platform to develop your skills working alongside a team of like-minded individuals. We been successfully implementing Engineering, Quality, Validation, Process Excellence and Product Dvelopement manufacturing solutions across companies in the medical device, healthcare, and life sciences sectors both nationally and internationally.

This is an excellent opportunity for an experienced candidate in quality systems and validation and technical realted documentation to develop their career. In this key role, the successful applicant will benefit from fantastic scope for career progression.
The successful candidate will be capable of interfacing with senior management within the organization and to work with and support the organization for the successful completion of specific objectives.

Responsibilities:

  • To provide support for the technical/validation documentation activities.
  • Ensuring that all compliance issues and requirements of Company Validation/Quality Policies and Procedures are addressed.
  • Establishes and manages engagement objectives, expectations, and quality plan.
  • Suggest and implement innovation and continuous improvement within the quality/validation process.
  • Builds cross functional and cross-departmental support, fostering overall effectiveness.
  • Ensure accuracy and consistency of the technical/validation documentation.
  • Ensure all quality/validation documents are authorized and appropriate compliance approval is gained
    Review and approval of change controls, nonconformance investigations, and protocols.
Qualifications & Experiemce:

  • Qualification in an appropriate discipline ie. Quality, Engineering, Information Systems, or Life Science with a broad technical/educational skills base.
  • Understanding of GMP, Compliance, Validation Practices including the system development life cycle and Regulatory expectations.
  • Experience working in a regulated environment would be an advantage.
  • Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
    An excellent working knowledge of Microsoft Office.
  • Strong interpersonal and communication skills and be able to work on your own initiative.


Additonal Keywords: Quality Assurance Assistant, Quality Assurance, Quality Control, QA, QC, Quality Documentation, Techncial Specialist, Validation Specialist, Design Control Specialist