The Topicals Supervisor will oversee all activities on the manufacturing floor, plan and schedule all manufacturing packaging activities to ensure deadlines are met in order to prevent back orders.
Essential Functions:
Oversee all activities on the manufacturing floor including: compounding/bulk processing, filling, and cartoning, of Creams and ointments. Ensure safety, quality, and effective productivity, adhering to 100% GMP compliance. Plan and schedule all manufacturing and packaging activities to ensure deadlines are met, prevent a back order situation.
Ensure that all SOPs are detailed, up to date, and operators are fully trained in the execution of all tasks. Issue daily work assignments to the operators on the production floor. Execute the monthly/daily production schedule to ensure 100% schedule compliance. Generate daily production reports to the Department Head, and notify the department head of any deviation from the schedule, or of any safety and/or compliance concerns that may negatively impact the production plan.
Work closely with the quality group to ensure constant compliance, participate in any and all investigations that may arise in the department. Participation with R&D in the development and execution of new products is expected, and will be a key contributor of information during the process.
Conduct effective communication to the staff on a daily basis to ensure that everyone is up to speed with the all pertinent departmental and/or company events.
Act as a "Working Supervisor" to manufacture the various R&D large/small scale batches, training operators in the processing and equipment capabilities for all cream and ointment production. The working Supervisor responsibility is a key aspect of the role as it pertains to leading, performing and demonstrating the actual methods and procedures in manufacturing the products using state-of-the-art equipment and operating systems. These systems include sophisticated recipe driven controlled human interface systems.
Additional Responsibilities:
Complies with all company policies and standards.
Conduct manufacturing of R&D ANDA batches and R&D scale-up batches. Perform Continuous improvements.
Participates with operator training.
Education:
High School or GED - Required
Experience:
4 years or more in Pharmaceutical, Manufacturing with previous Cream/Ointment experience
Skills:
Superior communication, both verbal and written instructions. - Intermediate
Demonstrated ability to supervise, train and coach manufacturing operators - Intermediate
Strong attention to detail. - Intermediate
Demonstrated time management and multitasking - Advanced
Strong leadership and interpersonal skills. - Advanced
Proficient in MS office suit. - Intermediate
Specialized Knowledge:
Knowledge of safety, cGMP and SOP, quality systems and quality assurance concepts, 21 CFR Parts 210 and 211.Knowledge of equipments with containment techniques. Hands on experience with Topical manufacturing equipment suchas Becomix, Ross mixer, HMI systems, tube and bottle filling machine, packaging equipment, ancillary equipment.
