Responsibilities :
- Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices.
- Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturing processes.
- Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and other departments to support process validation activities.
- Lead and / or participate in investigations related to process deviations, non-conformances, and CAPAs, and implement corrective and preventive actions as needed.
- Support technology transfer activities between development and manufacturing sites, ensuring successful scale-up and transfer of processes.
- Stay current with industry trends, regulatory requirements, and best practices related to process validation and contribute to the continuous improvement of validation processes and procedures.
Requirements :
- Bachelor's or master's degree in engineering, Pharmaceutical Sciences, or related field.
- Minimum of years of experience in process validation within the pharmaceutical or biotechnology industry.
- Strong understanding of regulatory requirements (, FDA, EMA, ICH) related to process validation.
- Experience with risk assessment methodologies (, FMEA) and statistical analysis tools (, Minitab) is preferred.
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