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