Trainee Officer - Manufacturing Science and Technology

Trainee Officer - MSAT

Job Description

Primary Job Responsibilities:

• Preparation / review of documents pertaining to tech transfer like Development report, Tech transfer report, MFR, BMR and BPR w.r.t. drug product.
• Review aseptic product filling operations such as formulation, filtration, filling, visual inspection and secondary packing operations on shop floor as and when required.
• Responsible in the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing).
• Work with R&D team in execution of scale up / scale down runs and any other related experiments to support manufacturing process changes and executing improvement trials for better productivity and robustness.
• Responsible for preparation of Process Validation protocols / reports and supporting PV on shop floor as and when required.
• Responsible for preparation of risk assessments, hold time protocols/reports etc. and writing technical documents such as scientific justification and evaluation.
• Supporting Process validation at other sites, monitoring batches, collection of data for trend analysis using statistical tools, troubleshooting the problems and investigations using investigation tools for root cause analysis in a holistic manner as and when required.
• Supporting regulatory for Dossier filing and giving technical inputs in respective sections.

 

Additional Job Responsibilities:

• Carryout the investigations of process deviations and provide shop floor support during investigations and involved in change control procedure to support the manufacturing.
• Review of process related change controls, deviations and CAPA, co-ordinate the approval process and follow up to close out.

Work Experience

0- 2 years

Education

Masters in Biotechnology

Competencies

Experience Level

Entry Level