Packaging Manager ( Pharma )
5 - 7 years experience • Biotech/Pharma
Title: Inspection and Packaging manager
Location: Columbus, Ohio
This position is a member of the Manufacturing Team. The Manufacturing Team is responsible for activities associated with the manufacture of safe, effective and sterile pharmaceuticals in accordance with company SOPs, policies and cGMPs. The Manufacturing Team ensure asepsis and sanitary conditions are maintained where required, that appropriate manufacturing area and equipment records are neat and accurate and that safe, effective, and professional behavior is displayed at all times. In conjunction with the Production Management the Manufacturing Team provides input and assistance to other Department as needed, playing a critical role in maintaining maintenance schedules and meeting company goals. . The Inspection & Packaging Manager will be able to participate in all aspects of the ManufacturingProcess. The ManufacturingProcess includes inspection, labeling, packaging and cartoning along with cleaning, assembling and collecting QC samples in accordance with established production records in a concerted effort to manufacture sterile liquid and lyophilized pharmaceuticals. The ManufacturingProcess includes fully automated inspection, labeling, and packaging, as well as manual inspection glass vials, and plastic bottles, and the tear-down and line clearances of the manufacturing equipment. The manufacturingtechnology utilized at PharmaForce Inc. – New Albany includes HMI-PLC/SCADA controlled Inspection, Labeling, and Packaging equipment. The Inspection & Packaging Manager will be able to oversee and provide signatory approval of all activities associated with the manufacturingprocess. The Inspection & Packaging Manager will be able to provide direction, training and mentorship to all Inspection and Packaging Staff, and Supervisors as needed. The Inspection & Packaging Manager will be the responsible person for the proper operation of the Inspection, Labeling, and Packaging equipment and ensure that all processes are in a compliant and inspection ready state. The Inspection & Packaging Manager will be the responsible person for the proper use of batch documentation. The Inspection & Packaging Manager will be able to troubleshoot most manufacturing processes and equipment and where necessary make adjustments and minor repairs during setup and during operations. The Inspection & Packaging Manager will be able to assist in technology transfer from R&D and provide input and assistance in creating Inspection and Packaging Batch Records.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Ensures equipment and supply inventories are maintained and available for use in accordance with production schedules.
• Ensures only approved materials and equipment are utilized at all times.
• Ensures that personnel do not perform tasks for which they do not have accurate and approved training records.
• Ensures that only approved documentation and procedures are utilized at all times.
• Coordinates scheduling activities with Filling Department to ensure timely processing of all product.
• Analyzes department performance and proactively identify and implement strategies to improve employee safety, product quality and productivity.
• Identifies and addresses individual/team training and development needs.
• Staffs Inspection and Packaging operating stations in support of production schedule.
• Ensures proper QC sampling techniques and procedures are utilized and ensures timely delivery of samples to the QC laboratory.
• Analyzes staffing needs and makes appropriate staffing adjustments.
• Assures GMP compliant operations are being performed by the Manufacturing Team.
• Attends all training programs as required by Company SOPs, procedures and policies.
• Develops operational tactics for manufacturing start up activities.
• Establishes and manages operating and capital budgets.
• Prepares for Pre-Approval Inspection.
• Prepares for and participates in regulatory audits.
• Ensures workplace safety and security within OSHA, EPA, DEA and all applicable governing body standards across manufacturing areas.
• Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
• Perform any other tasks/duties as assigned by management.
• We all must embrace the QUALITY culture.
QUALIFICATIONS AND REQUIREMENTS:
• High SchoolDiploma or GED Equivalent required. Bachelors’ Degree in Pharmaceutical Science, Chemistry, [Micro] Biology, Engineering or another relevant field is preferred.
• Experience with HMI-PLC/SCADA control data system preferred.
• Minimum 5 years supervisory experience in Inspection/Packaging or related experiencerequired.
• Experience with cGMP/FDA and fully automated inspection and packaging systems is required.
• Possesses good oral and written English communication and comprehension skills.
• Ability to perform basic mathematical calculations.
• Ability to take feedback constructively and function in a team oriented work environment.
PHYSICAL ENVIRONMENT AND PHYSICAL REQUIREMENTS
• While performing duties of the job, incumbent is occasionally required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.
• Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.
• Employee must be able to occasionally lift and/or move up to 50 pounds.