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Validation Specialist

2 months ago


Fredericton, New Brunswick, Canada SUN PHARMA Full time

Job Title: Validation Engineer

Company: Sun Pharmaceuticals

Job Summary: As a Validation Engineer at Sun Pharma, you will play a crucial role in ensuring the quality and compliance of our pharmaceutical products. Your primary responsibility will be to complete assigned equipment validation tasks to meet cGMP requirements in the oral solid dosage products segment.

Key Responsibilities:

  • Develop and execute validation protocols for production and packaging equipment, utilities, and area qualifications to ensure seamless integration and optimal performance.
  • Coordinate commissioning activities for new equipment to ensure timely and efficient deployment.
  • Review and execute Periodical Performance Verification of equipment to maintain high-quality standards.
  • Design and implement calibration plans for new equipment to ensure accuracy and precision.
  • Develop and maintain Standard Operating Procedures (SOPs) for equipment operation and maintenance to ensure consistency and efficiency.
  • Identify and troubleshoot deviations for projects to ensure timely resolution and minimal impact on production.
  • Assist in audit responses for regulatory agencies to demonstrate compliance and adherence to cGMP regulations.
  • Manage validation project plans and summary reports to ensure transparency and accountability.
  • Create and close change controls and investigations to ensure continuous improvement and quality enhancement.
  • Monitor work order status and follow up on maintenance tasks to ensure timely completion and minimal downtime.

Requirements:

  • Bachelor's Degree in Engineering or Science with a strong foundation in validation processes and cGMP regulations.
  • Technical expertise in validation processes and cGMP regulations with a focus on oral solid dosage products.
  • Strong communication and problem-solving skills with the ability to work effectively in a team-oriented environment.
  • Self-motivated and proactive with a strong commitment to quality and compliance.
  • Project management experience with a proven track record of delivering results in a fast-paced environment.

Language Proficiency: Intermediate-B1+ level

Benefits: Comprehensive benefits package including medical, dental, vision, life insurance, and retirement savings plan.

EEO Notice: Equal employment opportunities for all employees.

Note to Agencies: No unsolicited resumes accepted.