Manufacturing Company is looking for a Change Control Management Lead in Chatsworth.
Hours: 8:00am - 5:00pm
Days: Monday - Friday
Prepare, update and execute Validation Master Plan, which includes Installation Qualifications (IQs), Operational Qualifications (OQs), Performance Qualifications (PQs), Process Validations (PVs) and Cleaning Validations (CVs) in compliance with OTC drug cGMP standards.
• Develop and execute validation/qualification protocols for facilities, utilities and manufacturing/packaging equipment.
• Assist in the implementation of corporate policies and procedures relating to quality, process development, and cGMP compliance by establishing validation procedures for achieving reliability per specifications and procedures.
• Collect, statistically analyze, and develop final report packages to support all validations/qualifications to ensure that the products processed are proven to be reliable, safe, and effective.
• Work in close cooperation and collaboration with Production, R&D, Maintenance and Quality departments.
• Support test method validation activities.
• Participate in the investigation and resolution of all non-conforming (NCMR, OOS, and deviations) related incidents.
Bachelor’s degree in an engineering discipline.
• Minimum 3 years of hands-on process engineering experience; preferably in a pharmaceutical, biomedical, or medical device field (regulated industry).
• Prior experience with continuous improvement methods (Lean, Six sigma, or other programs)
• Experience with liquid filling operations.
• Experience with bath processes.
• In-depth knowledge of current Good Manufacturing Practices.
• Must be hands-on, results-oriented individual with demonstrated technical ability.
• Excellent analytical and problem-solving skills.
• Strong written and communication skills.
• Proficiency in MS Word, Excel and PowerPoint.