Quality Assurance QA Specialist

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About the role

About the job As a Quality Assurance (QA) Specialist, you play a key role in partnering with site GMP operations and validation team in solving complex problems to ensure quality, safety, reliability, efficiencies and manage multiple quality systems including, but not limited to change controls, validation, deviations, laboratory investigations and CAPAs. He/she will assist in the daily operations for Batch Record Review, Batch Disposition/Release, complex deviations and continuous improvement projects. He/she will also ensure the compliance of qualification and validation with applicable regulatory requirements and company quality standards. Accountabilities of the Quality Assurance (QA) Operations Specialist: • Reviewing batch records and associated documentation. Overseeing review and approval of batch records and associated documentation. • Overseeing batch release process to ensure compliance with regulatory requirements and company standards. • Ensuring batch release activities comply with Good Manufacturing Practices (GMP). • Collaborating closely with production to ensure quality standards are maintained throughout the product lifecycle • Reviewing and approving investigation by leading highly complex root cause investigations for manufactured batches that have been implicated by deviations/laboratory investigation. Ensure that investigations are deep dive and scientifically justified to withstand scrutiny during batch review/disposition/release decision. • Monitoring and analyzing batch release performance metrics. • Monitoring the progress of effective corrective and preventive (CAPA) actions to ensure timely closure of CAPA (key site performance metrics). Collaborate with site operation on problem prevention activities and system improvements. • Implementing continuous improvement initiatives to enhance batch release efficiency and effectiveness • Representing the site in the CoP led by global and, if requested, participating in the CoE for batch release and ensuring local communication. • Reviewing qualification and validation documentation, including protocols, reports, risk assessments, and traceability matrices according to pre-defined timeline. Ensuring proper documentation of deviations, non-conformances, and corrective actions. Ensuring proper evaluation (validation expertise) of change controls • Ensuring all qualification and validation activities comply with regulatory requirements (e.g., FDA, EMA) and company quality standards • Conducting regular audits of production processes to identify and address potential quality issues. • Participating in internal and external audits and regulatory inspections providing support and documentation. • Developing and implementing risk management strategies to mitigate potential quality issues. • Fostering a culture of quality and continuous improvement across the organization Other responsibilities: • Coordinates on the Annual Product Review (APR). • Participate actively in the GEMBA walk-down during investigation to triage and resolve on-the-floor manufacturing issues. • Training: To complete all GMP mandatory and related training. • Facilitate daily level 2 quality meeting. Backup as QA Executive for QA team. Support monthly joint GEMBA- backup as QA Specialists for QA team. • Play a proactive role by complying and adhering to HSE guidelines. Embrace Zero Incident Mindset and adopt the responsibility of HSE protection policies and Life Saving Rules (LSR).   Key involvement in decision-making process: • Approve documentation for batch disposition and update corresponding digital tool to allow release (D) • Approve a batch record if it is correctly completed and meets the quality requirement for one lot (D) • Check whether all practices are done

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