Regulated Pharmaceutical Process Lead

hace 1 día


San Juan, San Juan, Puerto Rico Qrc Group Llc A tiempo completo

We are looking for a Regulated Pharmaceutical Process Lead to join our team at Qrc Group Llc. As a key member of our organization, you will be responsible for leading efforts in designing, implementing, and improving aseptic processes and systems within a regulated pharmaceutical environment.

The successful candidate will have a strong background in aseptic processing, FDA product submissions, and validation activities. Key responsibilities include:

  • Designing, implementing, and improving aseptic processes and systems to ensure high-quality production and compliance with industry standards
  • Troubleshooting and resolving issues related to aseptic operations, ensuring compliance with cGMP and FDA guidelines
  • Providing technical expertise and documentation for aseptic processing and equipment validation activities
  • Developing, executing, and documenting validation protocols (IQ/OQ/PQ) for aseptic processes and manufacturing equipment
  • Leading investigations for deviations and CAPAs related to aseptic operations, ensuring timely and effective resolution

Key Qualifications:

  • Bachelor's or Master's Degree in Engineering, Pharmaceutical Sciences, or a related field
  • Minimum of 5-7 years of experience in aseptic process engineering, equipment validation, and FDA product submissions within a regulated pharmaceutical or biotech environment
  • Strong knowledge of aseptic processing and systems
  • Expertise in validation methodologies (IQ/OQ/PQ) and risk management
  • Familiarity with FDA regulations, cGMP guidelines, and industry standards


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