Operational Excellence Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeOperational Full time ₹ 1,04,000 - ₹ 1,30,878
Job Title: Operational Excellence Specialist

We are seeking an experienced Operational Excellence Specialist to join our team.

  • Key Responsibilities:
  • Develop and implement standard operating procedures (SOPs), batch manufacturing records, protocols, cleaning procedures, and log sheets in compliance with cGMP and regulatory requirements.
  • Maintain accurate documentation, ensuring all records are up-to-date and compliant.
  • Review and revise SOPs related to FP departments as necessary.

Quality Assurance & Compliance

  • Manage Quality Management System (QMS) activities, including change controls, deviations, incidents, and risk assessments.
  • Perform equipment qualifications (DQ, IQ, OQ, and PQ) to ensure smooth operations.
  • Support audit preparation and ensure all documentation is ready for audits.

Training, Team Management, and Production Execution

  • Coordinate employee training according to the TRIMS schedule.
  • Attend and participate in relevant training programs, including cGMP and equipment-specific SOPs.
  • Execute formulation and aseptic filling activities in line with the production plan.

Equipment Maintenance, Coordination, and Reporting

  • Collaborate with Engineering and QA to execute preventive maintenance plans.
  • Monitor equipment performance and take necessary actions to maintain uninterrupted operations.
  • Prepare and submit reports on daily activities, deviations, and issues to the reporting officer in a timely manner.

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