Quality Operations Expert II

About the Role

TheQuality Operations Expert II is responsible for providing Quality Assurance oversight forfinal 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 withGood 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

• Performfinal 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 resolveissues or deviations impacting batch release.
• Ensure all batch release and disposition activities are performed in compliance withGMP and applicable quality requirements.
• Participate inQuality Alert/Product Alert meetings, ensuring investigations and associated actions provide sufficient information to support lot disposition decisions.

Deviation & Investigation Management

• Act as theQA reviewer for site deviations, ensuring investigations are comprehensive, scientifically sound and completed in a timely manner.
• Lead and/or supportroot 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 forcomplaint investigations requiring site support, including coordination of investigation reports.

Quality Systems & Compliance

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

Continuous Improvement

• Identify and implementcontinuous 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 ininternal 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 least5 years of Quality Assurance experience within the pharmaceutical industry, with a strong focus ondeviation management and batch release/disposition processes.
• Strong knowledge and practical understanding ofGood Manufacturing Practices (GMP) and Quality Assurance principles.
• Experience supporting quality investigations, change controls and other pharmaceutical Quality systems.

Skills

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

Pursueprogress, discoverextraordinary

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