Strides Pharma Inc.
Operation Supervisor, Packaging - 1st Shift
Strides Pharma Inc., Chestnut Ridge, New York, United States
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. Executes procedures to complete tasks in a compliant and safe manner. Continuous Improvement
Captures and reports metrics; troubleshoots downtime to increase operational efficiency. Lead or participate in Continuous Improvement projects. Troubleshoots and resolves process issues. Issues & Deviations
Performs defect evaluations and initiates production events. Identifies, reports, and suggests resolutions for processing related issues. Assists in the investigation of unplanned deviations. Teamwork and collaboration
Provides priorities for the off-shift operations, focusing resources on priority products. Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues. Continuous Training
Ensures personnel are current with training requirements. Stays current on SOPs and cGMPs. Continuous Safety & Compliance
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. Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies. Misc
Other related duties as assigned to meet departmental and Company objectives. Education & Experience
Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute. Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging. Knowledge
Thorough knowledge of cGMP and FDA regulations. Thorough knowledge of manufacturing and packaging operations. Skills & Abilities
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.
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. Executes procedures to complete tasks in a compliant and safe manner. Continuous Improvement
Captures and reports metrics; troubleshoots downtime to increase operational efficiency. Lead or participate in Continuous Improvement projects. Troubleshoots and resolves process issues. Issues & Deviations
Performs defect evaluations and initiates production events. Identifies, reports, and suggests resolutions for processing related issues. Assists in the investigation of unplanned deviations. Teamwork and collaboration
Provides priorities for the off-shift operations, focusing resources on priority products. Interfaces with supervisors and/or Quality personnel to inform of deviations or other line issues. Continuous Training
Ensures personnel are current with training requirements. Stays current on SOPs and cGMPs. Continuous Safety & Compliance
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. Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies. Misc
Other related duties as assigned to meet departmental and Company objectives. Education & Experience
Bachelor's degree in Pharmacy, Chemistry, Engineering, or a related discipline preferred; relevant experience my substitute. Minimum of 3 years supervisory experience in pharmaceutical solid dosage manufacturing/packaging. Knowledge
Thorough knowledge of cGMP and FDA regulations. Thorough knowledge of manufacturing and packaging operations. Skills & Abilities
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.