Well-established and expanding pharmaceutical company is seeking an experienced Operations Supervisor to join their Packaging department. Hours are Monday - Friday, 7:00am - 3:30pm. Salary depends on experience. Company offers comprehensive benefits package.
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.
