Manager Filling & Pkg Staff

Manages people process within a process/product team to meet goals and priorities. Assures that operations are conducted in compliance with regulatory authorities. Responsible for the formulation of bacterial and viral bulk vaccine to meet established requirements. Assures that operations are conducted in compliance with cGMPs, CBER, WHO, EP and other regulatory bodies. Plans and initiates the overall production schedules, coordinating personnel activities with other Manufacturing staff. Reviews batch records for correctness and completeness. Overall responsibilities include employee selection, training, development, counseling recommendations for cost reductions, profit improvement opportunities, cost control, quality of product, incident investigations, managing departmental capital and operation's budgets. Chief duty involves providing managerial coverage for employees as required during first shift working hours. Additional responsibilities include determining and presenting technical process improvements and communicating issues to appropriate groups (e.g., IOC, Management Committee, staff meetings), and work unit teams. When necessary, coordinates Maintenance, Metrology, and Validation activities with applicable leaders. Takes a role in implementing new equipment and procedures. Performs all other duties as required by department management. Deviation management, people development, and Quality Assurance of the Aseptic Processing area are required. Background in Aseptic Processing is favorable. BS degree in Life Sciences, Engineering or equivalent with relevant experience in manufacturing and/or filling of biological products. 3-5 years experience in manufacturing and/or development departments. Must have previous experience in working with a production department of a pharmaceutical company. Working knowledge of cGMP's. Must have knowledge of continuous improvement techniques and problem solving skills. Excellent verbal and written communication skills. Working knowledge of SAP is preferred. Candidate must be able to work overtime.' R2482187
Salary Range: NA
Minimum Qualification
Less than 5 years

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