QA Contract Specialist

Posted 09 May 2022
SalaryNegotiable
LocationTipperary
DisciplineLife Science
ReferenceTR/054527_1652113150
Contact NameRonan Brady

Job description

Orion Group Life Sciences are currently recruiting a QA Contract Specialist on behalf of our Multinational Biopharmaceutical client based just outside Clonmel Co. Tipperary on an initial 11-month contract (with potential to extend).

Responsibilities:

  • Complete auditing/ review of batch documentation to ensure compliance to SOPs, GMPs and applicable regulations
  • Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.
  • Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
  • Utilise this network to help resolve comments and issues that arise during audit and review.
  • Manage product recalls and stock recoveries as appropriate.
  • Identify compliance gaps and make recommendations for continuous improvement
  • Create and maintain assigned SOPs.
  • Perform and review complaints and deviation investigations, change controls and CAPA's.
  • Assist in the induction process for new starters and training of other staff.
  • Generally, follows standard procedures and consults with manager/supervisor to ensure resolution of exceptions.
  • Compile data for reports and presentations, provide data interpretation, draw conclusions.
  • Carry out all assignments to the standards of compliance, efficiency, innovation, accuracy, and safety in accordance with Company and regulatory requirements.
  • Keeps abreast of cGMP requirements as described in applicable worldwide regulations.
  • Represents department on cross functional teams.
  • Assist in the generation, review, and approval of Technical & Quality Agreements.
  • Additional activities as assigned by the manager/supervisor Skills Required.

Knowledge, Skills, Experience:

  • The successful candidate is required to possess a degree in a Quality, Science or Engineering discipline and potentially a higher degree and/or significant industrial experience.
  • They must possess > 3 years industrial experience.
  • Experience should be in the pharmaceutical/chemical industry or government drug-regulatory agency with a working knowledge of cGMP regulations.

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.