Manufacturing Process Expert
Job Description
We are seeking a talented 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.
Key Responsibilities:
• Validation: Preparation, Review, Approval of MPR, Preparation, Review, Approval of process validation protocols, Compilation of validation report.
• Tech Transfer: Coordination with Vendor cross functional teams for Tech transfer activities, Execution of Tech transfer products at Receiving Units.
• QIP: Identifying root cause for QIP, Execution of QIP, Conclusion Recommendation of QIP.
• OOS OOT Investigation: Identifying probable and most probable root cause for OOS OOT.
Required Skills and Qualifications
Masters or Bachelors degree in Pharma, Minimum 6-8 years of experience in Process Development, MSAT, Tech Transfer.
Technical Skills: Experience in scale up technology transfer of products in relevant dosage forms or technologies (OSD), 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.
Benefits
Attractive compensation package, Joining assistance, Relocation support, Family support, Maternity and Paternity benefits, Learning and development opportunities, Medical coverage for yourself and your family, Life coverage for yourself.
About Us
We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. Our product development efforts drive a portfolio of more than 1,000 products.
Apply Now
We are seeking a talented 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.
Key Responsibilities:
• Validation: Preparation, Review, Approval of MPR, Preparation, Review, Approval of process validation protocols, Compilation of validation report.
• Tech Transfer: Coordination with Vendor cross functional teams for Tech transfer activities, Execution of Tech transfer products at Receiving Units.
• QIP: Identifying root cause for QIP, Execution of QIP, Conclusion Recommendation of QIP.
• OOS OOT Investigation: Identifying probable and most probable root cause for OOS OOT.
Required Skills and Qualifications
Masters or Bachelors degree in Pharma, Minimum 6-8 years of experience in Process Development, MSAT, Tech Transfer.
Technical Skills: Experience in scale up technology transfer of products in relevant dosage forms or technologies (OSD), 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.
Benefits
Attractive compensation package, Joining assistance, Relocation support, Family support, Maternity and Paternity benefits, Learning and development opportunities, Medical coverage for yourself and your family, Life coverage for yourself.
About Us
We are a science-driven innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API Formulations Clinical Intellectual Property and Regulatory Affairs. Our product development efforts drive a portfolio of more than 1,000 products.