APS Consultant
1 week ago
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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