Executive - QA Validation (Sterile-Injectable plant)

Alembic Pharmaceuticals; Padra; On-site; INR 500,000 - 700,000; Full time

Job summary

Alembic Pharmaceuticals in Gujarat seeks an Executive in Validation to drive validation activities for a Formulation-Injectable facility, ensuring compliance with regulatory requirements. You will develop and maintain the Validation Master Plan (VMP), prepare SOPs, review IA/QRM/FAT/SAT, and prepare protocols and reports for facility, utility, and equipment.

You will coordinate with departments and support regulatory submissions.

Qualifications

• Preparation and maintenance of Validation Master Plan (VMP).
• Review IA, QRM, FAT, SAT documents.
• Coordinate with departments for validation execution.
• Prepare validation protocols and reports.
• Support regulatory inspections.

Responsibilities

• Preparation of Validation Master Plan (VMP) for Formulation-Injectable facility in line with regulatory requirement and execution of validation activities in accordance with Validation Master Plan.
• Preparation of SOPs for validation as per requirement.
• Review of Impact assessment, QRM, FAT, SAT documents.
• Preparation of protocols and Report for Facility, Utility and Equipment
• Review the vendor protocols for adequacy and enhancement.
• To co-ordinate with concerned department for execution of validation activity
• To take part in execution for validation activity, compilation, and review of validation protocols
• Provide required technical inputs for investigations as part of qualification.
• Maintenance and periodical updation of requalification schedules.
• Provide adequate support for regulatory and customer inspections.
• Review of drawings (Wherever applicable).
• Provide required validation data to Regulatory Affairs department for regulatory submission.
• Any other responsibility as assigned by Head-Validation or designee.
• To coordinate for training regarding activities
• Preparation of procedures required for Validation.
• Preparation of Validation Master Plan and ensure that VMP is in updated state periodically.
• Review of IA, QRM, DQ, FAT, SAT and other qualification documents.
• Ensure submission of required validation data to Regulatory Affairs department for submission.
• Any other responsibility as assigned by reporting authority/ HOD.
• Preparation of Validation/Qualification protocols in line with VMP, coordinate for execution and preparation of summary reports.

Job description

Role & responsibilities for Executive - Validation

• Preparation of Validation Master Plan (VMP) for Formulation-Injectable facility in line with regulatory requirement and execution of validation activities in accordance with Validation Master Plan.
• Preparation of SOPs for validation as per requirement.
• Review of Impact assessment, QRM, FAT, SAT documents.
• Preparation of protocols and Report for Facility, Utility and Equipment
• Review the vendor protocols for adequacy and enhancement.
• To co-ordinate with concerned department for execution of validation activity
• To take part in execution for validation activity, compilation, and review of validation protocols
• Provide required technical inputs for investigations as part of qualification.
• Maintenance and periodical updation of requalification schedules.
• Provide adequate support for regulatory and customer inspections.
• Review of drawings (Wherever applicable).
• Provide required validation data to Regulatory Affairs department for regulatory submission.
• Any other responsibility as assigned by Head-Validation or designee.
• To coordinate for training regarding activities
• Preparation of procedures required for Validation.
• Preparation of Validation Master Plan and ensure that VMP is in updated state periodically.
• Review of IA, QRM, DQ, FAT, SAT and other qualification documents.
• Ensure submission of required validation data to Regulatory Affairs department for submission.
• Any other responsibility as assigned by reporting authority/ HOD.
• Preparation of Validation/Qualification protocols in line with VMP, coordinate for execution and preparation of summary reports.