QA Specialist (Shift)

  • Contract
  • Carlow

Website TPM05326

Summary:
Our client is a global bio pharmaceutical company based in the midlands is looking for a QA Specialist who will be responsible for ensuring that the process for the manufacture of drug product in compliance with cGMP and the associated regulatory requirements. The successful candidate will be responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations. Ensure that objectives are effectively achieved, consistent with company requirements to ensure compliance, safety and reliable supply to our customers.

Responsibilities:

  • Review and approval of all manufacturing batch documentation including electronic batch records, real time reports, master data using the site systems.
  • Review and approval of SOPs, cleaning verification/validation data and other documents as necessary for the operations department.
  • Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various Quality related systems; ensure all work is subsequently carried out in line with same.
  • Support the development and implementation of improved quality reporting measures.
  • Liaise with the Quality Specialists/QP/QA Lead to resolve queries relating to batch manufacturing process.
  • Work collaboratively to drive a safe and compliant culture on site.
  • Work shift patterns in line with manufacturing operations to ensure Quality oversight as required.
  • Provide effective real time on the floor support for day to day manufacturing operations for example area clearances, batch record reviews, aseptic operations.
  • Provide quality input into decision making process on the shop floor ensuring that product quality is maintained.
  • Provide training in all aspects of Quality Management Systems and GMP.
  • Ensure all work is carried out in line with SOPs, training or other quality systems such as change controls where applicable.
  • Facilitate compliance direction for the site by assisting in the adherence to divisional policies and guidelines as well as regulatory requirements.
  • Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site.
  • Actively participate in Plant/Quality committees and works with other site functional groups, such as the Microbiology Laboratory, Production, Utilities, Site Services, and Maintenance to help set direction for plant wide GMP initiatives.
  • Drive compliance with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Aid the effective implementation of the Quality Management System and facilitate the continuous improvement of same ensuring the Quality Management Systems are accurate and complete; review on a continuous basis.
  • Be an advocate of continuous improvement in the Quality Management Systems.
  • Partner with colleagues cross functionally to provide support and advice on day to day basis and on a project basis including communications, training, project work, audit/inspection duties, investigations, batch work, customer queries etc.; thereby ensuring operations is audit/inspection ready.
  • Conduct area inspections for operations as appropriate.
  • Initiate and maintain Quality related metrics, ensuring effective communication and follow up of same.
  • Monitoring of quality systems.
  • The self-inspection program.
  • Verification of the effective implementation of key GMP programs.
  • Effectiveness of Preventative Actions.
  • Leadership activities including selection, development, coaching, and day to day management.
  • Required to comply with Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Qualifications & Experience:

  • Degree in Quality, Science or similar required.
  • Relevant experience in a quality role, ideally in a pharmaceutical manufacturing environment.
  • Knowledge of US and European cGMP guidelines, and other international regulatory requirements, as applicable to the site.
  • GMP Audit experience in the pharmaceutical industry.

To apply for this job email your details to patricia.arrue-elorza@tandempm.ie.