QA Operational Readiness Officer

Our client, a leading pharmaceutical organization, is seeking a QA Operational Readiness Officer to support the startup of a new production facility. The project focuses on ensuring quality readiness, operational excellence, and regulatory compliance during the commissioning phase. This role is essential for managing the transition to operational status through meticulous batch record oversight and GMP adherence.

• Lead the review and approval of electronic Master Batch Records (eMBRs) ensuring alignment with GMP requirements and local procedures.
• Integrate site lessons learned and process improvements into new batch record templates to enhance compliance.
• Collaborate with manufacturing and process development teams to ensure MBR content reflects validated processes and specifications.
• Support the quality review of executed batch records during PQ and PPQ qualification runs.
• Manage the document lifecycle and version control of quality documentation within the QMS.
• Conduct routine GEMBA walks to validate that shop-floor practices align with documented instructions.
• Perform quality risk assessments for new processes and review qualification documentation to support project timelines.

• Bachelor’s degree in Life Sciences, Engineering, Quality Management, or a related field.
• You have 3+ years of experience in pharmaceutical or biotech quality assurance.
• You possess experience in quality assurance including MBR authoring, batch record review, and compliance management.
• You bring a strong understanding of GMP standards and pharmaceutical manufacturing technologies.
• You're recognized for your analytical abilities, attention to detail, and effective stakeholder management skills.

Nice to Haves

• Experience managing priorities within a fast-paced project environment.
• Willingness to collaborate with cross-functional teams and external contractors.

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