QA Specialist

• Provide overall quality direction for processes and procedures associated with all aspects of new equipment introduction, including Computerised System Validation

• Act as the Quality point of contact and decision-maker for C & Q / Validation execution activities, ensuring all activities comply with regulatory and company standards.

• Lead Quality review and approval of validation documentation associated with new facilities and new product introduction

• Lead QA review and approval of SAP BOMs, MBRs and recipes as applicable.

• Partner cross-functionally with PD, Engineering, and Operations teams to ensure all NPI activities are compliant with regulatory and Site Quality Requirements.

• Provide Quality Direction and input for Change Controls, CAPAs, and Deviation Investigations.

• Support Inspection Readiness and Regulatory Audits, representing QA for Validation and NPI areas.

• Conduct risk assessments and develop mitigation strategies for potential challenges in equipment / product introduction.

• Provide input and Quality Oversight for change control development and implementation.

• Ensure timely and robust implementation of change controls and CAPA records.

• Write, review, and approve Standard Operating Procedures (SOPs) in alignment with the clients policies.

• Ensure all activities align with the clients safety standards, SOPs, and regulatory expectations.

• Support a safe working environment by adhering to all environmental health and safety practices, rules, and regulations.

• University degree in a Science-related discipline.

• Minimum of 7 years' relevant experience in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for key functional areas (i.e. Process Development, Validation, Manufacturing)

• In-depth knowledge of applicable regulatory requirements and experience with regulatory inspections.

• Experience working in aseptic operations, relating to vial and syringe filling.

• Understanding of principles of Validation and New Product Introduction

• Proven experience in Quality Systems (change control, non-conformance, corrective and preventative actions)

• Strong organizational skills with the ability to manage tasks through to completion.

• Ability to work independently and remotely with minimum direct supervision.

• Strong critical thinking and problem-solving abilities

• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.

• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.
• Demonstrated ability in providing leadership to cross-functional teams to advance complex projects to completion. Excellent Communication skills are essential for this role.

Morgan McKinley