Engineering & Electronics

QA Specialist

  • Contract
  • Remote
  • Munster
  • 41948525

The Role:

QA Specialist required to join an expanding team in Cork to help support the Quality Operations unit.

Responsibilities:

  • 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 JSCI by 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

Education and Experience:

  • Bachelors Degree in a scientific/technical discipline required
  • A minimum of 5 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.

 

Desirable:

  • Advanced degree (MS, MBA, PhD) preferred
  • Experience in C&Q, and Process validation
  • Experience in direct interactions with regulatory agencies during site inspections.

 

Interested candidates should submit an updated CV.

Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to William.cunnage@peglobal.net 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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