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Engineering & Technical

Job Description

QA SPECIALISTS x 2 required by CareerWise Recruitment for our Biologics client in Cork, initial 12 month contract on offer. The QA SPECIALISTS will manage compliance activities and QA operational activities including C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.

Role of this position

  • 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 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.

JOB REQUIREMENTS

  • Bachelors Degree 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.
  • Experience in C&Q, and Process validation
  • Experience in direct interactions with regulatory agencies during site inspections.

Please call Conor Twomey today for further information on 021 4297422 or email: ctwomey@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin. By applying for this position, you are consenting to allow CareerWise Recruitment to process and retain your data in accordance with our Privacy Policy, contained on our website for the purposes of providing career opportunities. CareerWise Recruitment accepts that you do not wish your personal data, including your CV, to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will always be respected. Please feel free to contact us if you have any queries or wish to withdraw or amend your consent.

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Engineering & Technical

Cork Office

CareerWise Recruitment. EastGate Village, EastGate, Little Island, Cork.

Phone: +353 (0) 21 206 1900

Email: info@careerwise.ie