Hybrid QA Specialist

at PSC Biotech Corporation

• Job title: QA Specialist
• Job type: Contract
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Carlow, Ireland

About the role

• Quality Assurance Specialist ensuring compliance in pharmaceutical materials and processes. Oversight on new product introductions and quality assurance in a hybrid environment.

Responsibilities

• Provide quality oversight and direction for the introduction of new products and materials, as well as manage external parties.
• Provide QA oversight to support Analytical, Warehouse and Facilities Management, including deviations, Root cause analysis, CAPAs and change controls
• Participate as a functional expert in the cross-functional team responsible for introducing products and materials
• Review documentation associated with new product and material introduction, such as Material Packs, QC Test Specifications, BOMs, Supplier Qualification and Oversight.
• Develop and monitor supplier performance metrics, participate in material review boards and quarterly reviews of key suppliers, and actively engage in cross-functional forums as needed.
• Maintain the approved supplier management list within the qualified Supplier Management system, ensuring correct setup of suppliers and materials used
• Support deviation and atypical closeout, as well as initiate and follow up on corrective and preventive actions.
• Author, review, and approve protocols and reports for technology transfer, method qualification, and method validation.
• Conduct quality reviews and approvals of engineering/validation/automation/utilities commissioning and qualification activities.
• Serve as the point of contact for quality at both the site level and with external inputs, coordinating and attending Quality working group meetings.
• Facilitate compliance direction for the site by adhering to divisional policies, guidelines, and regulatory requirements.
• Proactively evaluate site compliance against emerging trends and initiate major compliance initiatives for improved status and operational efficiency.
• Actively participate in Plant/Quality committees and collaborate with other site functional groups.

Requirements

• A minimum of 3-5 years of experience in a quality role, ideally in a pharmaceutical manufacturing environment.
• Knowledge of regulatory/code requirements related to Irish, European, and International Codes, Standards, and Practices.
• Familiarity with cGMP (current Good Manufacturing Practice) and GDP (Good Distribution Practice) is preferred.
• Strong report, standards, and policy writing skills.
• Experience with equipment and process validation.
• Familiarity with sterile filling processes and equipment.
• Proficiency in Microsoft Office and job-related computer applications.
• Experience or familiarity with Lean Six Sigma methodology is desired.
• Good collaboration skills and the ability to work effectively as part of a team to determine priorities.
• Demonstrated ability to work independently and take ownership of improvement initiatives with a moderate level of guidance.
• Proven ability to drive the completion of tasks.
• Strong decision-making capability with a sense of accountability and responsibility.
• Demonstrated problem-solving skills.

Benefits

• Employee Value Proposition
• Learning & Development in-house training mentorship through constant guidance
• Empowering career development