APS Consultant

2 days ago

Boston, United States i-Pharm GxP Full time

Position: APS Consultant

Company: Leading Pharmaceutical Company


Join a globally recognized pharmaceutical leader dedicated to delivering ground-breaking solutions that improve lives. With decades of expertise and a strong focus on innovation, this company drives advancements in healthcare through cutting-edge therapies, strategic partnerships, and a patient-centric approach.


They are currently seeking an Aseptic Processing Simulation (APS) Consultant to contribute their expertise in ensuring the integrity of critical manufacturing processes in a cGMP environment.


Key Responsibilities

  • Lead the execution and documentation of Aseptic Processing Simulations (APS) to ensure compliance with cGMP and regulatory standards.
  • Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Engineering, to optimize APS activities.
  • Validate and support the implementation of single-use systems within manufacturing processes.
  • Assist in the development, revision, and management of critical documentation, such as batch records, deviation reports, and CAPAs.
  • Provide expertise in sterilization validation and execution, ensuring adherence to best practices and regulations.
  • Ensure project milestones and deadlines are met through efficient planning and execution of APS initiatives.
  • Participate in regulatory and internal audits, presenting APS documentation and addressing inquiries.
  • Stay current with industry trends, regulatory changes, and advancements in aseptic processing technologies.


Qualifications

  • Bachelor’s degree in a scientific, engineering, or health-related field.
  • 5+ years of experience in cGMP manufacturing, with a strong focus on aseptic processing and validation.
  • Comprehensive knowledge of APS execution, including regulatory requirements and industry best practices.
  • Proficient in technical writing, particularly for validation and compliance documentation.
  • Proven ability to address non-conformances through effective problem-solving and corrective actions.
  • Strong interpersonal and communication skills, with the ability to influence decisions and collaborate across teams.
  • Experience representing validation processes in audits or inspections is a plus.


If you’re ready to contribute your expertise to a world-class pharmaceutical company, we’d love to hear from you Please send your updated resume or let us know a convenient time for a discussion.

Not the right fit? We welcome referrals—successful recommendations may qualify for our referral program.

Reach out to me at Jwilson@i-pharmconsulting.com

*NO C2C POSSIBLE - DO NOT REACH OUT FOR C2C*

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