Contamination Control Specialist (6 months contract)
Summary
Oversee contamination control and sterility assurance in a pharmaceutical environment, analyzing microbiological data, leading investigations, and ensuring GMP compliance.
About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
This role is responsible for supporting the site's contamination control and sterility assurance programme by monitoring microbiological and environmental data, leading investigations and CAPAs, conducting risk assessments, and ensuring GMP compliance. Working closely with cross-functional teams, the incumbent drives contamination control improvements, supports validation activities, and helps maintain product quality and inspection readiness.
Key Responsibilities
- Leading as SME for specific subjects as part of the Contamination Control SOP in her/his area of expertise
- Conducting risk assessments related to contamination control
- Overseeing site activities and performance for contamination control systems in her/his scope of responsibilities
- Leading investigation following contamination control failures and proposing corrective and preventive actions (CAPA)
- Collaborating with cross-functional teams to ensure product quality
- Ensuring presence on the shop floor to oversee practices, identify gaps vs SOP for contamination control
- Reviewing data from contamination control monitoring to propose improvements as necessary (from monitoring and trends)
- Supporting the preparation of validation protocol and supporting projects related to her/his area of expertise
- Perform microbiological trend analysis for environmental monitoring (EM), utilities, personnel monitoring, and contamination control programme
- Analyze microbiological investigation data to identify trends, recurring issues, and potential contamination risks
- Prepare and present contamination control trend reports, providing meaningful insights and recommendations
- Lead or support microbiological investigations, including root cause analysis (RCA), CAPAs, and effectiveness checks
Required Qualifications
- Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
- Experience in sterility assurance and microbiological or contamination control within a pharmaceutical or biotechnology environment
- Ability to meticulously review and analyze documentation, processes, and products to ensure compliance with the global operating procedures and Quality standards
- In-depth knowledge of regulatory requirements and Good Manufacturing Practices (GMP) relevant to sterility assurance and microbiological control
- Communication skills to communicate with a large number of functions (from shopfloor to management) and to present complex subjects
- Ability to organize and lead routine investigations with a multi-disciplinary team
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.