MSAT Manufacturing Specialist

1 week ago

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

We are seeking a Technology Transfer professional to support the development and implementation of robust manufacturing processes, including authoring validation protocols and reports, conducting risk assessments, and utilizing advanced tools for process monitoring and analysis.

Roles & Responsibilities
  • Responsible for Validation which shall include: Preparation/Review/Approve of MPR. Preparation/Review/Approve of process validation protocols. Preparation/Review/Approve & compilation of validation report.
  • Responsible for Tech transfer which shall include: Coordination with cross functional teams for Tech transfer activities. Execution of Tech transfer products at Receiving Units.
  • Responsible for QIP which shall include: Identifying root cause for QIP. Execution of QIP. Conclusion/Recommendation of QIP.
  • Responsible for OOS/OOT investigation which shall include: Identifying probable and most probable root cause for OOS/OOT.
Qualifications

Educational qualification: Masters/Bachelors/Ph.D in pharma

Minimum work experience: 6-8 years of experience in Process development / MSAT / Tech transfer

Skills & Attributes

Technical Skills

  • Experience in the scale up/ technology transfer of products in relevant dosage forms or technologies. (OSD)
  • Experience in process Engineering, Quality by Design (QbD) principles and risk assessment approaches.
  • Knowledge of International Council for Harmonization (ICH) guidelines related to Product development or Process Development.

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