Quality Operations Expert II

About the Role

The Quality Operations Expert II is responsible for providing Quality Assurance oversight for final drug substance disposition, batch release, deviation management, change control and Product Quality Review activities.

The role works closely with Manufacturing, Quality, Regulatory and other site stakeholders to ensure products are appropriately assessed and dispositioned in accordance with Good Manufacturing Practices (GMP), site quality requirements and applicable regulatory standards.

The incumbent will also support quality investigations, audits and continuous improvement initiatives to strengthen site quality systems and operational effectiveness.

Key Responsibilities

Batch Disposition & Release

• Perform final drug substance disposition for release to secondary customers.
• Review batch-related quality information and ensure all requirements are satisfactorily completed prior to disposition.
• Investigate and resolve issues or deviations impacting batch release.
• Ensure all batch release and disposition activities are performed in compliance with GMP and applicable quality requirements.
• Participate in Quality Alert/Product Alert meetings, ensuring investigations and associated actions provide sufficient information to support lot disposition decisions.

Deviation & Investigation Management

• Act as the QA reviewer for site deviations, ensuring investigations are comprehensive, scientifically sound and completed in a timely manner.
• Lead and/or support root cause analysis investigations for quality incidents and ensure appropriate corrective and preventive measures are identified.
• Review investigation outcomes and assess potential impact to product quality and batch disposition.
• Serve as the operational Quality point of contact for complaint investigations requiring site support, including coordination of investigation reports.

Quality Systems & Compliance

• Review, assess and approve site change controls, ensuring potential quality and regulatory impacts are appropriately evaluated.
• Perform Product Quality Reviews (PQR) in accordance with site and regulatory requirements.
• Collaborate with the Regulatory Support Officer to ensure compliance with applicable local and international regulatory requirements.
• Ensure activities are performed in accordance with GMP, site procedures and established Quality Assurance principles.

Continuous Improvement

• Identify and implement continuous improvement initiatives to strengthen deviation investigation processes, progress monitoring and overall effectiveness.
• Review performance metrics and trends to identify opportunities for improvement.
• Support improvements to Quality systems and operational processes while maintaining regulatory compliance.

Audits & Inspections

• Participate in internal and external audits and regulatory inspections.
• Support inspection readiness activities and provide Quality documentation and subject matter support as required.
• Support follow-up and closure of observations and associated actions where applicable.

Skills & Experience

Experience

• At least 5 years of Quality Assurance experience within the pharmaceutical industry, with a strong focus on deviation management and batch release/disposition processes.
• Strong knowledge and practical understanding of Good Manufacturing Practices (GMP) and Quality Assurance principles.
• Experience supporting quality investigations, change controls and other pharmaceutical Quality systems.

Skills

• Strong capability to investigate, assess and resolve quality issues or deviations efficiently.
• Good analytical and problem-solving skills, including experience with root cause analysis.
• Ability to analyse performance metrics and trends and identify areas for improvement.
• Strong organisational and project management skills, with the ability to manage multiple priorities and activities simultaneously.
• Effective cross-functional communication and stakeholder management skills.
• Ability to operate effectively in an ambiguous, dynamic and fast-changing environment.
• Strong attention to detail with a commitment to quality, compliance and timely execution.