Sterile Operations Manager
Posted on: January 16, 2022
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
- 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
- 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
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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