Normal business hours - 8-5

Bachelor degree

• This position is responsible for supporting the assessment and Quality integration plan relating to integration of assets.
• Responsible for designing, developing and implementing Third-Party Quality strategies and quality oversight for external GMP services provided to Client R&D to ensure that Client external providers of critical services (CMOs) comply with Client data integrity and quality standards, GxP regulations and meet national health authority requirements.
• Promote and implement a Quality and Safety culture within Client R&D.
• Provide Client business owners and third parties with GMP expertise and regulatory compliance advisory and act as a valuable source to Client R&D for the selection of GMP suppliers for vaccine R&D projects allocated, while promoting operational efficiency, continuous improvement and contributing to R&D pipeline acceleration.

Key Responsibilities:

• Assess the current Quality Posture of External Partners to identify any key risks or required Quality Improvement activities
• Perform Operational Quality oversight of Third Parties, including Deviations, Change Controls, CAPAs and Batch Release Activities for Drug Substance and Drug Product.
• Performance management of project workstream activities
• Escalate serious cGMP/Regulatory compliance issues following internal procedures
• Building relationships with cross functional team and stakeholders
• Performance manage quality plans for projects
• Ensure business continuity in a changing environment, supporting sites internal / external
• Encourage collaboration across Client to ensure cross-functional input to key decisions and initiatives
• Identify and manage Quality and Compliance risks that arise from projects
• Proactively drive a mindset of continuous improvement of processes, value creation and costs savings without compromising compliance, quality or customer service across the team
• Drive robust RCA and problem solving mindset and use of tools across organisation and ensuring CAPAs are implemented to address root causes

Experience in the following areas:

• Demonstrated experience and understanding of GMP
• Demonstrated project management skills
• Risk Management
• Knowledge of applicable manufacturing and packaging processes and basic technical competence
• Knowledge of PSC network and supply capability
• Problem solving skills
• Excellent communication skills

Rangam Consultants is a minority, women-owned, disability workforce solutions global organization. We specialize in attracting and retaining talent globally for rewarding careers in IT, Engineering, Scientific, Clinical, Healthcare, Administrative, Finance, Business Management, and many more, while integrating veterans and individuals with disabilities into the workforce. Indeed, we connect career aspirants to relevant job opportunities, whether in the USA, UK, India, or Ireland. Additionally, we offer Flexible Work Arrangement jobs and contract positions across different verticals and industries.
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