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Biologics Design Control Specialist

1 week ago

Chennai, Tamil Nadu, India Pfizer Full time

About the Job:


The Biologics Design Control Specialist will be a key member of our team, responsible for ensuring that combination product development activities are compliant with quality and regulatory standards. This includes supporting the planning, coordination, execution, and communication of design control activities.



Duties:

  • Function as a team member and be involved in cross-functional teams across many Pfizer sites in the United States, Europe, and India
  • Collaborate with cross-functional development teams to ensure deliverables of the team
  • Ensure that combination product development activities are compliant with quality and regulatory standards - both internal and external
  • Support device design and manufacturing investigations from devices used in clinical trials and commercial manufacture
  • Manage risks within project and investigate opportunities for novel approaches to resolve issues and problems


Requirements:

  • Bachelor's or Master's degree in Biotechnology, Biochemistry, Biomedical, Mechanical, Materials, Chemical Engineering, or other related discipline
  • Minimum 1-2 years of experience in Biopharmaceutical Industry Medical Device industry with interdisciplinary drug product or combo product development knowledge
  • Thorough working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, ISO 11040, and the EU Medical Devices Directive
  • Working knowledge of EN 62366 HE75 and EU Medical Devices Regulation
  • Knowledge of current US and global Regulations, FDA and ICH guidance, ISO standards for syringes injectors, luer connectors, and quality system regulations