Pharmaceutical Process Expert

3 days ago

Goa, India beBeeProcess Full time

This role involves designing and optimizing manufacturing processes to meet technical requirements for regulated markets.

Responsibilities
  1. Develop and refine manufacturing processes to ensure compliance with regulatory guidelines.
  2. Evaluate process effectiveness using design of experiments (DoE) and quality by design (QbD) principles.
  3. Assess site suitability based on formulation and process complexity.
  4. Liaise between development and manufacturing teams to facilitate technology transfer and scale-up.
  5. Define procedures for product transfer, ensuring seamless execution and accurate filings.
  6. Provide subject matter expertise in pharmaceutical processes and technologies, offering guidance on tech transfer, troubleshooting, and investigations.
  7. Establish standards for formulation technology transfer and serve as the primary point of contact for these activities.
  8. Promote capacity enhancement, cost reduction, and time cycle reduction initiatives within the organization.
  9. Review and approve departmental standard operating procedures (SOPs) to ensure adherence to current Good Manufacturing Practices (cGMP) and quality assurance (CQA) guidelines.
Desired Skills
  • Expertise in formulation development and process optimization.
  • Hands-on experience in technology transfer and scale-up.
  • Familiarity with regulatory frameworks such as USFDA, EMA, and WHO.
  • Strong documentation, communication, and analytical skills.
  • Able to work in a fast-paced environment and manage multiple projects concurrently.
  • Effective project management and cross-functional coordination skills.

This is an exciting opportunity for experienced professionals to apply their skills and expertise to drive innovation and growth in the pharmaceutical industry.

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