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QA Specialist

  • Job reference: 927998
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 02/10/2019

Orion Group are looking for a QA Specialist for our multinational pharmaceutical client based in the Cork area on an initial 12-month contract with the potential to extend.


Job Purpose

Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.


Main Responsibilities of the role

  • 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

Desired Experience and Background of the successful candidate

  • Bachelor's 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
  • Advanced degree (MS, MBA, PhD) preferred
  • Experience in C&Q, and Process validation desirable
  • Experience in direct interactions with regulatory agencies during site inspections.
  • Experience in a similar role within a FDA/EMEA regulated environment
  • Excellent interpersonal skills
  • Ability to operate as part of a team is critical
  • Good problem solving skills
  • Results and performance driven

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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