QA Specialist

The purpose of this role is to work within and support the Global Development Quality Assurance team at the facility. This role will primarily provide support for Change Control, Deviation Management and Supplier Quality Management. It will also support interface of SAP with IPI Product structure and MES BOMs and recipes. Other activities to support Quality Systems and QA Operations will be required as per start up schedule.

The QA Systems and Compliance Team with work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the MSD Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.

The role is required to:

• Participate daily on cross-functional teams to collaboratively actively to address compliance issues and achieve project milestones.
• Participate in and lead investigation of deviations, risk assessments and changes, ensuring appropriate actions are implemented timely.
• Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the facility.
• Provide QA oversight to GMP readiness, technical transfers, regulatory approvals and clinical operations at the facility.
• Assist in the development of training curricula and records for QA and providing SME training on Quality Assurance SOPs as required.
• Assist in the creation and maintenance of QA SOPs, metrics and reports in line with site requirements.
• Support an environment of continuous improvement by identifying and implementing efficiencies and quality improvements.
• Ensure the escalation of compliance risks to management in a timely manner.

What skills you will need:

In order to excel in this role, you will more than likely have:

• Bachelor's degree, or higher (Science/Quality/Technical).
• 4-5 years' experience, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
• Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Strong written and verbal communication skills.
• Ability to think logically and be proactive under the variable schedules of a startup site.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience in quality management systems such as Veeva, SAP, PAS-X, Delta V, Trackwise etc.
• Knowledge of industrial regulations including those of FDA, HPRA, EMEA and other authorities related to Biologics and/or Pharmaceuticals.

Desirable:

• Experience in direct interactions with regulatory agencies during site inspection.
• Previous experience working in a sterile/low bioburden environment.