Quality Assurance Specialist

3 weeks ago

Municipal District of Carlow, Ireland eTeam Full time

Job Description

  • Role: Associate Specialist, Quality Assurance
  • Work Location: Carlow, Ireland
  • Contract type: 11-month contract
  • Client: A global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines to improve human and animal health. With a strong commitment to research and development, the company focuses on addressing some of the world's most pressing health challenges.

ABOUT THE ROLE:

You would be responsible for ensuring that drug product manufacturing at our Carlow site complies with cGMP and all relevant regulatory requirements. This role involves reviewing and approving GMP documentation to support corporate compliance and regulatory expectations for manufacturing operations. Additionally, it ensures that objectives are met effectively, aligning with the company's standards to guarantee compliance, safety, and a reliable supply to customers.

Key Responsibilities

Documentation:

  • 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 IPT 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.

Quality Oversight:

  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • 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 work 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 Merck 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.

Continuous Improvement:

  • Partner with colleagues cross-functionally to provide support and advice on a 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 IPT is audit/inspection ready. Conduct area inspections for IPT as appropriate.
  • Initiate and maintain Quality related metrics, ensuring effective communication and follow-up of same. Such ongoing monitoring/metrics gathering may include:
  • 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. Ensure that the team receives appropriate resources and programs to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programs.
  • Required to comply with company Global and regulatory requirements and execute current good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
  • Work collaboratively to drive a safe and compliant culture in Carlow.
  • May be required to perform other duties as assigned.

ABOUT THE CANDIDATE:

What skills you will need:

  • Third Level Degree qualified in a Science/Technical or related discipline.
  • 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.
  • Problem-solving / critical thinking – ability to understand connections between different technical/quality system areas and recognize potential compliance issues and trends.
  • Communication, decision-making, people influencing, and project management skills will be important.
  • Report, standards, policy writing skills required.
  • Demonstrated ability to make and act on decisions while balancing speed, quality and risk.
  • Ability to provide innovative ideas to improve quality and compliance that create value including seeking new information and external insights.
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