Q&V Coordinator - Quality, Dahanu, ACG Capsules

1. Job Objective

• Timely execution of the Validation Master Plan (VMP).
• Preparation and execution of all protocols related to qualification and validation.
• Timely execution of Qualification of all new machine / Instrument / equipment.
• Monthly details status report

1. Primary responsibilities

Strategic and planning

Functional

Core

• Prepare Validation master plan annually and ensure adherence to schedule for qualification and validation of equipment / instrument / area etc.
• Prepare and get the protocol reviewed and approved prior to execution of the Validation activity.
• Participate in validation and qualification as per the approved protocol.
• Work with the user department in listing down the observations as per the approved and executed protocol.
• The conclusion drawn from the Validation / Qualification to be shared with the QA / Quality Head.
• Working with the Engineering Team / Calibration team with compliance with SAP.
• Support the DMS system implementation across the plant.

Internal process

• Adherence to schedule for validation and qualification

• Qualifications (IQ/OQ/PQ) of all new machines / Equipment.

• Validation of the process to be carried out as per the stipulated frequency.

Authorities

• Authorised for final release of finished product batches
• To raise and approve QMS documents like change control, deviation, OOS, Investigation, etc.
• To authorize print request of documents in Document Management System (DMS)
• Authorized to publish SOP. Formats in DMS

People development

Training to Management associates (MA) on details of Validation and Qualification

Training to Plant associates (PA) on the Basis concept of Validation and Qualification.

1. Key Result Areas

• Proper planning before starting Qualification and Validation activities.
• Involvement of the cross functional team.
• Real time data entry
• Study to be carried out only after Pre-Approval has been approved.
• Status report on a monthly basis.