Technology Transfer and Process Development Expert

3 days ago

Chandigarh, Chandigarh, India beBeeManufacturing Full time ₹ 1,04,000 - ₹ 1,30,878
About the Role

Our organization is seeking a seasoned Manufacturing Science and Technology (MSAT) Specialist to support the development and implementation of robust manufacturing processes. This role involves authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis.

The ideal candidate will actively participate in technology transfers, continuous improvement initiatives, and ensure compliance across manufacturing operations.

Key Responsibilities:
  • Prepare and review Master Production Records (MPRs), validation protocols, and reports.
  • Coordinate with vendors and cross-functional teams for technology transfer activities.
  • Execute technology transfer products at Receiving Units.
  • Identify root causes for Quality Improvement Projects (QIPs).
  • Investigate Out-of-Specification/Out-of-Trend (OOS/OOT) issues.
  • Ensure validations are conducted as per protocol and qualification protocols meet cGMP and regulatory requirements.

Requirements:

Educational Qualifications: A Master's/Bachelor's degree in Pharmacy or a related field.

Minimum Work Experience: 6-8 years of experience in Process Development/MSAT/Tech Transfer.

Skills & Attributes:

  • Experience in scaling up/technology transfer of products in relevant dosage forms or technologies.
  • Process engineering expertise and knowledge of Quality by Design (QbD) principles.
  • Understanding of International Council for Harmonization (ICH) guidelines related to Product Development or Process Development.

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