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Pharmaceutical Process Development Specialist
2 weeks ago
PSC Biotech Ltd. is a renowned biotech consultancy firm with a strong presence globally. Our expertise spans software solutions for quality management, regulatory inspections, pharmaceutical contract manufacturing, and metrology services.
Our company culture revolves around our Employee Value Proposition (EVP), which empowers our professionals to work with talented cohorts in the Pharma/Biotech industry. We offer permanent contracts of employment with exposure to top pharmaceutical client sites in diverse cultural settings.
Our teams focus on delivering seamless NPI to our multi-product facility. The successful candidate will collaborate with stakeholders to execute transfer requirements for late-stage clinical and/or PPQ programs.
Responsibilities:
- Collaborate with stakeholders to execute the transfer requirements of both late-stage clinical and/or PPQ programs.
- Attend meetings with local and international groups to coordinate and execute implementation tasks for new Drug Substance processes.
- Manage new program introduction schedule to ensure tasks are executed on schedule and right-first-time.
- Collaborate with stakeholders to deliver GMP documents related to TT, such as Risk assessments, change controls, batch records, sampling plans, Bills of Material.
- Support development of process descriptions, process models, facility fits, and other Tech Transfer-related documents for continuous and fed-batch processes.
- Employ innovative and continuous improvement mindset to identify and implement opportunities to enable product launch.
- Ensure the highest Quality, Compliance and Safety standards and embody Safe by Choice – know and follow the Safety, Health and Environment guidelines and work towards company safety and environmental goals.
- Ability to solve problems and take new perspectives on existing solutions with a desire to continuously learn, improve and develop.
- Excellent trouble shooting and problem-solving skills as well as influencing, collaboration skills and teamworking ability to work with global and interdisciplinary teams.
