Validation Technical Expert
Dr. Reddy's Laboratories, Inc. - Bristol, TN

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Job Title: Validation Technical Expert

Job Location: Bristol, Tennessee
  • Provide technical support to Quality Assurance / Manufacturing operations in respect to Process Capability and Validation.
  • Serve as technical resource to develop actions for opportunities such as batch scale changes, Master Batch Record revisions, process or formulation improvements, etc.
  • Prepare Validation and Production Support Study (PSS) protocols, Sampling and Testing (S&T) Plans, and comprehensive Summary reports.
  • Prepare cleaning, process, equipment and computer Validation protocols / Summary reports.
  • Conduct protocol-related training.
  • Perform physical properties testing and limited calibrations of test-related equipment.
  • Conduct Level 1 (self) audits and assist with other audits including FDA inspection.
  • Assist with maintaining historical and current validation documentation.
  • Assign validation protocol numbers through Access Database and update/maintain information accordingly post-execution.
  • Author or provide input to the “Process Validation” section of Annual Product Reviews.
  • Prepare or revise site Master Validation Plans, as needed.
  • Prepare Process Flow Diagrams (PFDs) for inclusion in protocols.
  • Support incident investigations as needed.
  • Interface with raw material / processing equipment vendors’ technical support staff to evaluate process or quality failures or to seek areas of improvement.
  • Knowledge of formulation, processing techniques and manufacturing trouble-shooting.
  • Knowledge of statistics and statistical process control.
  • BS degree in Industrial Engineering, Chemistry, Mechanical Engineering or other related discipline.
  • Minimum of 3 years experience in a pharmaceutical, consumer or related industry.
  • Knowledge of cGMPs and FDA regulations.
  • Knowledge of OE (Operational Excellence) concepts and tools.
  • Experience with equipment, computer, process, and cleaning validation.
  • Experience with Microsoft Word, Excel, statistical, and database software.
  • Strong written and oral communication skills.
  • Strong interpersonal skills.
  • Prefer experience in manufacturing process trouble-shooting.
  • Prefer experience in Statistical Process Control
  • Prefer experience in Lean Manufacturing and Six Sigma principles

About this company
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Established in 1984, Dr. Reddy’s Laboratories (NYSE: RDY) is an emerging global pharmaceutical company. As a fully integrated...