• Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility.
• Ensure that the development and maintenance process are adequate in order, for the system to meet its objective.
• Responsible for document preparation and execution of validation protocols for a wide range of manufacturing equipment.
• Review validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations.
• Qualify the equipment based on cGMP (Good Manufacturing Practices) standards.
• Review Laminar & Terminal HEPA filter certification performance qualification procedures.
• Author and executed Qualification Protocols for HVAC’s, Freezers and controlled temperature units.
• Assist in development of Quality Control Systems in compliance with Part 820 of CFR Part 11.
• Qualify parts washer by following cGMP standards and using advanced quality control techniques.
• Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU) and generated the final qualification reports.
• Qualify parts washer by following cGMP standards and using advanced quality control techniques.
• Conduct thermal mapping studies using Data Loggers and Kaye Validator.
• Work along with the production team to increase the Quality standards of the product filling line and validation related activities.
• Author and Initiator of Events and Quality Assurance Reports in Global Quality tracking system using Track wise.
• Initiate Work orders and Action Items using EAMS

Minimum requirements:

• Bachelor’s in Pharmacy or Equivalent is required
• 1-5 years relevant experience
• Strong technical writing to develop client SOPs
• Excellent communication skills
• Excellent attention to detail, analytical and problem-solving skills
• Experience in writing IQ, OQ and PQ protocols
• Knowledge of GMPs, GDPs, GLPs