Senior QA Specialist

Senior QA Specialist

Responsibilities

• Provide QA support for External Manufacturer, based in Ireland. Contribute to the ongoing technology transfers, inspection readiness, implementation, and execution of quality systems in support of the external manufacture of pharmaceutical large molecules (drug substance manufacturing).
• Support the External Quality account owner on tech transfers and projects as assigned.
• The position requires solid knowledge in all quality systems concerning the manufacture of biological drug substance and extensive knowledge of Quality Assurance, Quality Control and Compliance.
• Demonstrated ability to operate with a minimum of supervision. Demonstrated ability to take ownership for and lead the resolution of complex Quality and Compliance issues.
• Position requires travel to External Manufacturer’s sites to provide cGMP assistance and quality oversight.
• Serve as a contact point within the QA organization and Build relationships and influence external partners to continuously enhance quality culture and business excellence.
• Provide QA oversight for technology transfer including process validation, method transfer and cold chain implementation.
• Review and approve validation related documentation authored by both client and company
• Perform review of equipment and facility qualification, environmental monitoring, technical documents, raw material specifications, analytical methods, sampling plans, and master batch records to ensure products and processes comply with cGMP requirements.
• Conduct quality investigations and provide timely input to support close out with a minimum impact on the supply chain.
• Lead the development of corrective action plans and monitor implementation.
• Review batch documentation of products in scope prior to their release by the external manufacturer’s quality unit
• Coordinate change control documentation and approval process.
• Ensure the timely supply of Product Quality Reports (PQRs) from the external manufacturer according to schedule. Carry out a documented review of PQRs.
• Pro-actively identify risks and potential issues and delays and, where possible, resolve them. Where resolution is not possible, escalation to the relevant level of management is necessary.
• Assess current quality systems and recommend improvements in order to enhance quality and reduce cycle time.
• Ensure that all relevant QA related concerns at the external manufacturer sites are raised to the External Quality Account Owner.

Requirements

• Bachelors Degree in engineering, science, or an equivalent technical discipline
• Work experience: 10+ years relevant industry experience
• Extensive (> 5 y) knowledge of GMP, specifically biological drug substance experience is preferred (QA and/or production).
• Experience managing quality oversight for production and Technology Transfers
• Able to connect easily, team worker, able to manage across cultures
• Able to work independently while managing stakeholders, to handle complexity, and to take ownership for deliverables, as well as flexibility and confirmed collaboration skills, are required
• Excellent verbal and written communication skills, including ability to effectively communicate with internal and external customers.
• Excellent analytical skill to identify gaps and root causes of issues and think out of the box to develop a solution. Ability to quickly process complex information and make critical decisions with limited information
• Proficient in written and spoken English
• Excellent computer proficiency e.g. MS Office, Quality Systems
• Amount of travel: up to 50% on site presence at CMO (candidate must be located in proximity of Dundalk, Ireland).

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