MSAT Specialist

We are seeking a Technology Transfer team member 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. Your role will involve active participation in technology transfers, continuous improvement initiatives, and ensuring compliance across manufacturing operations.

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 Vendor/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.
• Ensure that validations is carried out as per the protocol & qualification protocols meets the cGMP & regulatory requirements.
• Follow up & coordinate with cross functional team for execution of validation.
• Give the input for the monthly reporting system, participate in the internal & external audits, present the documents to auditor's/inspection team.

Qualifications

Educational qualification:

Minimum work experience: 6

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.