Operation Supervisor, Packaging - 1st Shift
hace 10 días
Spring Valley
Job Description Job Summary The Operations Supervisor is responsible for overseeing solid dosage pharmaceutical manufacturing and packaging activities during 1st shift operations, 7:00am to 3:30pm. This role ensures that all production operations comply with cGMP, safety standards, and production schedules. The operations supervisor will lead and support a team of leads and operators ensuring high quality output, operational efficiency, and a safe working environment. Oversees and coordinates Manufacturing and Packaging operations. Responsibilities • Lead and supervise operations in solid dosage manufacturing and packaging to ensure adherence to Master Formula and Master Packaging Records, SOP’s, and regulatory requirements (FDA, etc.)., • Communicate with department leadership, set the shift schedule, and conduct shift huddle/communication at start of shift to ensure effective communication between shifts., • Ensure timely execution of production schedules., • Monitors manufacturing and packaging processes to ensure schedule is met within standards., • Review and complete shift documentation, including batch documentation, logbooks, etc., • Coordinate with Engineering and Quality Assurance to address any equipment issues that occur during the shift, • Support investigations for deviations that occur during the shift. Assist in determining and implementing CAPA., • Provide training, guidance, and performance feedback for shift employees. Ensure training requirements are met. Support employee development and cross-training., • Captures and reports metrics; troubleshoots downtime to increase operational efficiency., • Lead or participate in Continuous Improvement projects., • Performs defect evaluations and initiates production events., • Identifies, reports, and suggests resolutions for processing related issues., • Provides priorities for the off-shift operations, focusing resources on priority products., • Ensures personnel are current with training requirements., • Contribute to safety audits., • Ensures out manufacturing/packaging activities safely, as required, on a daily basis., • Follows all safety and compliance procedures and participates in required training., • Adheres to all cGMP compliance/regulatory mandates and quality requirements., • Participate in safety teams, start-up discussions, incident debriefs, etc., • Bachelor’s degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute., • Thorough knowledge of cGMP and FDA regulations., • Demonstrated leadership, communication, and decision-making skills., • Ability to oversee and manage the daily operations of manufacturing and packaging., • Ability to monitors processes to ensure schedule is met within standards., • Ability to analyze metrics and troubleshoot downtime., • Effectively interfaces with Quality Assurance to inform of deviations or other line issues., • Demonstrates the ability to work in collaboration with others as a part of a team., • Ability to lead in Continuous Improvement projects., • Posses technical writing skills.