Team Member - Qualification

Job Summary

We are looking for an individual for the qualification team to manage the documentation and execution of qualification activities, including the preparation, review, and execution of various qualification documents. The ideal candidate will oversee new project-related tests, review and compile raw data, and ensure compliance with validation master plans and SOPs. Additionally, responsibilities include implementing corrective and preventive actions, conducting incident investigations, and providing support during regulatory inspections.

Roles & Responsibilities

• You will be responsible for documentation and execution of qualification activities. This includes preparation, review and execution of URS (User Requirement Specification), DQ (Design Qualification), FDS (Functional Design Specification), UTM (User Traceability Matrix), IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), RQ and (Requirement Qualification) documents.

• Your responsibilities include review of miscellaneous qualification documents and preparation and review of risk assessments for equipment and systems.

• You will be responsible for new project related FAT (Factory Acceptance Test) and SAT (Site Acceptance Test).

• You will review and compile raw data, relevant certificates, analysis test reports and

• preparation and review of final summary report.

• You will be responsible for preparation and review of protocols and reports for media fill validation and cleaning validation.

• Your role involves initiation of relevant CRN (Change Request Number) for new or existing activity, timely closure of assigned action plans as per CRN, and CRN review and approval.

• You will be responsible for corrective and Preventive Action (CAPA) implementation and handling of incident investigations and CAPA related to qualification.

• As part of your role, you will prepare and review VMP (Validation Master Plan).

• You will conduct training for employees and external vendors as a qualified trainer.

• Your role includes preparation and review of qualification SOPs (Standard Operating Procedure), conducting investigations as a site investigation team member, and updating Qualification status label.

• You will be responsible for periodic qualification schedule preparation, updating and execution, and qualification of new or transferred equipment.

• You will also provide necessary assistance and support to various regulatory, internal and external inspections.

Function: Other
Experience Level: Mid-Senior Level