Responsibilities

• Coordinate qualification and re-qualification activities (IQ/OQ/PQ/CSV) for pharmaceutical facilities, critical utilities, qc equipment and production equipment used in manufacturing process.
• Prepare documentation and execute the activity for qualification and re-qualification activities such as IQ/OQ/PQ/CSV protocol and report.
• Conduct training of personnel pertaining to qualification and re-qualification activities.
• Maintain qualification or re-qualification schedule as per SOP.
• Perform quality risk assessments where necessary and participate in relevant department quality risk assessments.
• Maintain VMP and CSVMP as per SOP.
• Prepare and execute Qualification Planner for day-to-day activity.
• Perform any other tasks assigned by superior when deemed necessary.

Requirements

• Bachelor’s degree in science, engineering, manufacturing technology or closely related field is required.
• Minimum of 2 years of relevant experience in validation is required. 1-2 years of experience in the pharmaceutical industry is strongly preferred.
• Experience developing and executing process, equipment, and cleaning validation protocols.
• Knowledge of cGMP practices and standards.
• Required skill(s): Communication skill (both verbal and written), Interpersonal skill, Project Management skill
• Ability to work both independently and in partnership with others; proven ability to use
initiative and drive to achieve results