Description:
The QA Operational Readiness Officer is responsible for ensuring quality readiness, operational excellence and compliance for the successful startup and commissioning of a new production facility. This critical role coordinates quality-related activities during the facility qualification phase, ensuring seamless transition from construction to operational status while maintaining full regulatory compliance and GMP standards.
Key Responsibilities
Daily Quality Operations:
* Provide real-time quality support to project teams
* Review quality event investigations including root cause analysis, CAPAs, and effectiveness checks, ensuring timely completion
* Escalate critical quality issues to management
* Review and assess change control requests for quality impact and ensure proper documentation and approval of quality-related changes
* Conduct routine GEMBA walks
* Maintain and update quality management system documentation
Operational Readiness:
* Ensure compliance with local and international GMP requirements
* Support quality readiness plans for the introduction of a new production facility
* Conduct readiness assessments and gap analyses for quality systems and processes
* Coordinate cross-functional readiness activities with manufacturing, supply chain, and regulatory teams
* Follow-up on quality aspects of facility qualification including DQ, IQ, OQ, and PQ protocols and coordinate with engineering teams on quality-critical facility systems (HVAC, water systems, utilities)
* Support facility design qualification and compliance with regulatory requirements
* Support regulatory submission activities and quality sections preparation
* Support pre-approval inspections (PAI) and regulatory authority visits
Risk Assessment & Mitigation:
* Conduct quality risk assessments for new processes and procedures
* Identify potential quality impacts and develop mitigation strategies
* Monitor risk indicators and implement preventive measures
Required Qualifications
* At least Bachelor's degree in Life Sciences, Engineering, Quality Management, or related field
* 4-6 years of experience in pharmaceutical/biotech quality assurance
Core Competencies:
* Strong knowledge of GMP regulations and pharmaceutical quality systems
* Understanding of risk and change management principles and methodologies
* Strong analytical and problem-solving abilities
* Effective communication and stakeholder management skills
* Attention to detail with strategic thinking capability
* Understanding of pharmaceutical manufacturing processes and technologies
* Ability to work with cross-functional teams and external contractors
* Experience managing multiple priorities in fast-paced environment