Validation-Assistant Manager

MJ Biopharm; Pune District; On-site; INR 600,000 - 900,000; Full time

Job summary

MJ Biopharm is seeking a candidate to lead validation and qualification activities at our Pune site. The role involves planning, executing, and reviewing Validation Master Plans, protocols, and reports, coordinating with user departments, and training staff on related SOPs.

The successful person will compile data, prepare reports for approvals, and liaise with external agencies for qualification, validation, and calibration services.

Qualifications

• Experience with validation and qualification activities in pharma manufacturing.

Responsibilities

• Preparation and review of Validation Master Plan, Monthly and yearly Schedules.
• Planning and execution of the validation activity with co-ordination with user department.
• Preparation and review of Protocol and report as per the validation schedule.
• Provide training to personals involving validation and qualification activities on related protocols and SOP.
• Execution of schedule / planned validation as per the Protocol.
• Qualification/ Validation - Data compilation and Report preparation and approval.
• Review and compilation of data generated in validation and qualification studies.
• Coordination with external agency for Qualification, validation, calibration and outside services related to Qualification and Validation.
• Qualification of External agency for Qualification, Validation and Calibration agency as per the SOP.
• Undertake scheduled Process Validation, Cleaning validation, hold time study and other validations as and when warranted.

Skills

Validation

Documentation

Data analysis

GxP compliance

Tools

Validation protocols

Job description

Validation and Qualification Activity

• Preparation and review of Validation Master Plan, Monthly and yearly Schedules.
• Planning and execution of the validation activity with co-ordination with user department.
• Preparation and review of Protocol and report as per the validation schedule.
• Provide training to personals involving validation and qualification activities on related protocols and SOP.
• Execution of schedule / planned validation as per the Protocol.
• Qualification/ Validation - Data compilation and Report preparation and approval.
• Review and compilation of data generated in validation and qualification studies.
• Coordination with external agency for Qualification, validation, calibration and outside services related to Qualification and Validation.
• Qualification of External agency for Qualification, Validation and Calibration agency as per the SOP.
• Undertake scheduled Process Validation, Cleaning validation, hold time study and other validations as and when warranted.