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Sterile Operations Manager

Company: Medix---
Location: Somerset
Posted on: January 16, 2022

Job Description:

The Sterile Operations Manager is the most responsible person for the development of procedures and practices necessary for the manufacturing of sterile pharmaceutical products. This person will aid in the design, layout, qualification and start-up of a new manufacturing facility for injectable and ophthalmic products. This position will be responsible for hiring, management and performance of both salaried and hourly direct reports.
ESSENTIAL JOB RESPONSIBILITIES

  • Responsible for the development, training, implementation and approval of all sterile production documentation, procedures and manufacturing records
  • Overseeing the development, qualification, validation, and documentation of manufacturing systems, equipment, and processes for aseptically manufactured products
  • Demonstrating effective writing skills for drafting SOP's, batch records, protocols and reports
  • Overseeing validation activities, including IQ/OQ/PQ's on new manufacturing equipment and providing support and guidance to Engineering and Quality Assurance departments.
  • Responsible for supporting the scale-up and optimization of current and new manufacturing processes within the company.
  • Evaluating and optimizing manufacturing processes and keeping manufacturing areas inspection ready at all times
  • Demonstrating and applying a thorough understanding of engineering and scientific principles related to pharmaceutical manufacturing
  • Maintaining up to date knowledge with respect to relevant state-of-the-art technology, equipment, and/or systems
  • Ensure GMP compliance with applicable US laws, rules, and regulations and maintaining knowledge of cGMP compliance
  • Establishes and conforms to departmental budgets
  • Representing the company in a professional manner in all interactions with other employees, customers and suppliers
    REQUIREMENTS:Education - Bachelor's degree in a scientific field
    Experience - Minimum 10 years' experience in sterile pharmaceutical manufacturing including sterile formulation, fill and finishing operations. Previous experience in a supervisory position.

Keywords: Medix---, Trenton , Sterile Operations Manager, Executive , Somerset, New Jersey

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