The Company
Our client is the world’s largest and most broadly based healthcare company. Their aim is to improve access to a healthier lifestyle for everyone thanks to their research in different health areas including personal care products, MedTech and pharmaceutical products.
Role Description
The Staff Scientist MQSA (Microbiological Quality & Sterility Assurance) is a global subject matter expert responsible for driving sterility assurance and microbiological quality strategies across the product lifecycle. The role supports new product development, manufacturing, and regulatory compliance, with a focus on aseptic processing, sterilization, and contamination control.
Responsibilities
- Lead sterility assurance strategy for new product introductions and lifecycle management.
- Oversee validation and transfer of sterilization processes (e.g., EO, gamma, e-beam, moist/dry heat) and microbiological methods
- Support manufacturing sites and external partners through audits, supplier selection, and technical assessments.
- Ensure compliance with global regulations and support regulatory submissions and inspections.
- Drive contamination control strategies, environmental monitoring, and cleanroom and water system validation.
- Lead investigations, CAPAs, and continuous improvement initiatives related to sterility risks.
- Collaborate cross-functionally (R&D, Quality, Manufacturing) and provide technical training and guidance.
- Represent the organization in industry forums and stay current with evolving standards.
Requirements
- Bachelor’s degree in Microbiology, Biology, Engineering, or related field (MSc/PhD preferred).
- Minimum 8 years of experience in medical device or pharmaceutical environments (GMP/ISO).
- Strong expertise in microbiology, sterilization validation, and environmental control.
- Experience with regulatory inspections, audits, and technical problem-solving.
- Strong stakeholder management and cross-functional collaboration skills.
- Ability to lead technical initiatives and influence globally.
- Excellent communication and organizational skills.
- Knowledge of global sterility assurance standards and practices.
- Proficiency in standard office and analytical tools.
Other information
Apply to our vacancy for more information. Looking forward to getting in touch!
58180
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Prasad Nasina
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