The Qualification Officer will be responsible for conducting qualification activities as well as maintaining all documentation related to Qualification.

Start date: Candidate must begin working within a reasonable period.

Roles and Responsibilities

• Responsible for Qualification activities at the OSD facility like Equipment/instrument qualification, Area qualification, CSV, Utilities validation/qualification etc.
• Preparation and review of protocols and reports for Qualification of equipment, utilities and validation of computerized systems.
• Tracking of qualification activities as per the site Validation Master Plan and ensure that they are implemented as per schedule.
• Responsible for development and implementation of procedures and instructions applicable to Qualification activities.
• Responsible for the retention and control of qualification related documentation at the facility.
• Responsible for area qualifications and temperature mapping studies.
• Initiate and participate in change control management and assess impact on systems, utilities and equipment along with all activities related to QMS (Quality management system).
• Participate in risk management activities applicable to qualification.
• Participate in qualification investigation and implement corrective and preventive actions.
• Participate in qualification of Utilities like HVAC system, Water systems and compressed air.
• Work directly with external service providers hired for Qualification activities and ensure that all work is done according to the applicable standards agreed between the company and service providers.
• Participate in audits and inspection and ensure readiness for the site with respect to qualification status.
• Compliance with relevant regulatory requirements, cGMP, and other industry standards.
• Identifying and addressing deviations and non-conformances in qualification activities.
• Responsible for maintenance and execution of schedules related to qualification activities.
• Support and review validation related activities

Qualifications

• Bachelor’s degree in pharmacy, pharmaceutical sciences, Instrument engineering or chemistry

Experience

• 03-04 years of practical experience in qualification activities in a OSD pharmaceutical manufacturing industry or hands-on experience on all activities related to Qualification and validation.