Company Name: Actavis, Inc. Import
Job Details
Duration: Permanent
Min Education: Not Specified
Salary: Commensurate
Job Type: Full Time
Min Experience: Not Specified
Required Travel:
Location:
  • USA - Ft. Lauderdale Florida, 33301
Job Description
Description

Carries out responsibilities in accordance with the organization's policies, procedures, and state, federal and local laws. * Provides assistance in troubleshooting to manufacturing and packaging areas. * Interfaces with Quality Assurance and Research and Development (R&D) on process requirements for new and current products. * Works in conjunction with maintenance department to identify, recommend and implement the upgrade of current equipment and the purchase of new equipment within regulatory requirements. * Analyzes new and existing equipment, recommends equipment modifications as needed for validation optimization. * Performs studies to support necessary equipment and system IQ, OQ, and PQ's to assure compliance in all manufacturing and support areas. * Assists with on-site transfer projects and product scale-up activities. * Recommends improvements in manufacturing and control systems. * Reviews mechanical, specifications in manufacturer and blue print form, and identify critical parameters. * Analyzes statistical data, product or functional specifications to determine conformance with standards and established quality requirements. * Review and approve protocols that challenge the critical parameters related to installation, operation, and performance of the related facility, utilities, computer systems, or equipment. * Assures that protocols are approved through proper channels; writes and revises validation protocols. * Executes validation protocols per related SOPs and assures that acceptance criterion related to validation and qualification protocols are met. * Interacts with all effected personnel in the execution of protocols and gathering of test data. Assures that all test data is gathered and recorded in accordance with cGMP requirements. * Analyzes data to ascertain if it meets related protocol acceptance criteria; writes deviation reports as required upon failures to meet protocol acceptance criteria. * Writes final reports and assures that they are approved through proper channels. * Coordinates resources from engineering, research and development, technical services, quality assurance and production personnel assigned to specific projects. Furnishes direction to engineers and technicians with regard to project requirements. Develops and communicates project timelines and status. * Reviews and critiques investigation reports, protocols batch records and CMC documentation. * Provides timely updates to management on the status of various projects. * Provides technical training and assistance to others. * Oversees, participates in and approves the interviewing, hiring, and training of departmental employees. Conducts performance evaluation for direct reports. * Provides coaching and assistance to direct reports in the areas of disciplinary action, employee training, problem resolution and work assignment delegation. * Complies with all GMP and safety requirements, SOP's and Company policies and procedures. * Performs related duties as assigned.Qualifications

Interpreting mechanical blue prints and specifications. * Good technical writing skills for complex reports and regulatory documents. * Ability to prepare all types of pharmaceutical documentation (BR, BOM, CC, protocols, summary reports, evaluation reports). * Good decision-making, communication, presentation and troubleshooting skills. * Ability to handle multiple projects, duties and assignments. * Ability to guide a team as well as work and contribute in a team environment. * Solving practical problems and considering a variety of concrete variables in situations where only limited standardization exists. * Communicating clearly and concisely, both orally and in writing. * Establishing and maintaining good relationships with those encountered in the course of work. * Operating a personal computer. * Leadership skills for providing guidance to assigned personnel. * Managing, organizing, delegating assignments and reviewing work of assigned department staff; recruiting, interviewing, and selecting applicants in accordance with established employment practices and methods. * Assuring compliance with company policies, practices and procedures, including safety rules and regulation. Incumbents in this class are subject to extended periods of sitting, standing, walking, pushing and pulling, stooping and crouching climbing and walking, vision to monitor, occasional lifting of equipment or materials weighing up to 25 pounds. Incumbents may be exposed to toxic materials, toxic gases, electrical hazards, and dangerous tools and equipment. Work is performed in a manufacturing environment.Education

Bachelor's degree in a Science related field from an accredited college or university with eleven (11) to fourteen (14) years related experience; or an equivalent combination of education and experience. Graduate degree preferred. *LI-JE1