Manufacturing Science and Technology Consultant
4 weeks ago
About the Role:
We are seeking a highly skilled Manufacturing Science and Technology Consultant to join our team at NNIT. As a key member of our consultancy, you will play a crucial role in providing expert services to our international healthcare clients in strategically relevant projects.
Responsibilities:
- Develop and implement risk-based commissioning, qualification, and validation strategies for pharmaceutical and biopharmaceutical clients.
- Conduct system impact assessments, develop protocols, and create reports that support qualification and validation requirements in the industry.
- Design and develop validation protocols using a science and risk-based approach that meets regulatory requirements and industry best practices.
- Analyze and interpret system and process performance data to inform report and presentation to management.
- Investigate deviations, write investigation reports, and create summary reports.
Requirements:
- At least a Bachelor's degree in a technical discipline such as Engineering or Science, or relevant experience in the pharmaceutical industry.
- 3 or more years of experience in commissioning, qualification, validation, quality systems, quality operations, manufacturing, engineering, and technology transfer.
- Foundational understanding of ICH Q7, Q8, ICH Q9, ISO 14644, ANSI Z1.4, and other regulatory requirements.
- Experience with investigations into manufacturing/laboratory deviations and determination of product impact potential, root cause, and corrective/preventive actions.
- Knowledge of the Validation Lifecycle approach, guidelines, international regulatory requirements, and industry best practices.
About Us:
As a leading consulting organization, we offer excellent career development and growth opportunities, a structured training program, and peer mentoring system to support competence and personal growth. Our team is highly motivated and dedicated to delivering high-quality services to our clients.
What We Offer:
- Consulting roles with international healthcare clients in strategically relevant projects.
- Working in a professional consultancy environment with a highly motivated team.
- Opportunity to take on leadership responsibilities and help shape our organization.
- Excellent career development and growth opportunities.
Contact Us:
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