Process Validation/Senior Scientist

Category: Process Validation/Scientist Overview: Monitor/provide technical support for oral solid dosage validation processes.

Write protocols, execute and write reports for process and cleaning validation.

Develop Validation standard operational procedures.

Ensure compliance with current Drug Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), Andrx policies, and all applicable regulatory agencies.

Write/revise master batch records.Responsibilities:
Strive to raise awareness to the importance of “first-time quality” at development, technical support, and validation levels to eliminate the broad negative impact on effectiveness, costs, and quality down line.
Organize and carry out designated day-to-day project operations in support of high quality product development / scale up and technical support and efficient cost effective Process Development Operations.
Ensure compliance with current Drug Enforcement Administration (DEA), Good Manufacturing Practices (cGMP), Andrx policies, and all applicable regulatory agencies.
Participate in decision-making and achievement of business goals by demonstrating depth and breadth of technical knowledge and good communication skills in cross-functional environments.Job Requirements
Experience:
7Qualifications:
B.S. degree in Pharmacy / Chemical Engineering discipline with a minimum of 7 years experience.
The candidate must have experience in Pharmaceutical processes/optimization, equipment, validation and technology transfer. Knowledge of SUPAC (Scale Up and Post Approval Changes), cGMPs, and validation guidance is mandatory. Solid problem solving technique is required.