QA Specialist (18 Months)

  • Cork
  • Contract
  • JO-1901-64101_1546445754

Summary

General Duties
* Supports GMP activities from operational through to Laboratory support programs.
* Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
* Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
* Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
* Participates as a key quality member in inspections and audits of external parties/agencies.
* Key participant within the QA team in the execution of their duties.
* Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
* Domestic and international travel may be required.

Requirements:
* BSc in a scientific/technical discipline required
* A minimum of 3 years' experience in a quality 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 including those of FDA, HPRA, EMEA and other authorities
* Focus on patients and customers at all times
* Excellent interpersonal skills
* Ability to operate as part of a team is critical
* Customer focus

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