Develop and implement the documentation and systems required to support a pharmaceutical Quality Management System (QMS) in compliance with the expectations and requirements of current Good Manufacturing Practice (cGMP) regulations,
Essential Duties and Responsibilities
Prepare the documents and procedures required to be the building blocks of a robust Quality Management Systems.
Create the Quality Manual, the various Standard Operating Procedures (SOPs) defining the Quality Assurance functions (e.g., Site Master File including facility qualification and maintenance plan, Training procedure for GMP practices, Change Management, Investigations, Management Corrective / Preventive Actions (CAPAs), Complaints Management, Design History Files, Equipment Qualification System, Validation System, Training Manual & Plan, Material Management Plan etc.)
Work with Transpire Bio’s engineering contractors to evaluate the documentation existing, available, and required for the qualification of laboratory and manufacturing facilities projects and critical supporting systems (e.g., HVAC’s, Purified Water, Steam and other utilities ).
Consult with Transpire Bio’s internal and external resources to ensure that Transpire Bio’s facility in Weston, FL will have the quality management system, policies, practices and training commensurate with the requirements of a facility that develops and manufactures non-aseptic and aseptic products and that such an effort will ensure compliance with EU Annex 1 and US FDA requirements for aseptic processing facilities.
Track compliance issues within all departments and ensure completion within defined timelines.
Disseminate written policies and procedures related to compliance activities.
Advise internal management or business partners on the implementation or operation of compliance programs.
Qualification Requirements
BSc degree with minimum 10 years or MS with a minimum of 7 years of pharmaceutical industry experience in quality assurance/quality control or an equivalent combination of education and experience in a scientific or health-rated field.
Extensive knowledge and full understanding of GLP, cGMP, QMS and CAPA related tools or systems is required.
Experience with aseptic fill – finish operations and processing, is a must to have.
Experience with developing site master files, is a must to have.
Experience with facility and equipment qualification and validation plans is preferred.
Experience with drug-device combination products including CFR 812 and ISO13485 is preferred.
Experience with all aspects of microbiology as applied to aseptic fill-finish is preferred. A microbiology background is preferred.
Experience with establishing and defining specifications for the facility environmental viable and non-viable monitoring is preferred.
Experience with third party audits and quality agreements is preferred.
Working knowledge of applicable US FDA, USP and state board regulatory requirements and guidelines as applicable to the pharmaceutical industry.
Strong personal leadership with demonstrated competency interfacing with senior leaders is required.
Professional and concise written communications –exceptional attention to detail.
Strong organizational skills, with the ability to effectively prioritize and manage multiple projects and tasks, with attention to detail.
Strong interpersonal skills and the ability to assist personnel in a matrix organization, ability to proactively resolve issues in a diplomatic, flexible, and constructive manner.
Highly ethical, self-motivated and self-directed; works effectively independently as well as in a team environment.
Strong project management skills: MS Word, Excel, PowerPoint.
At Transpire Bio, our mission is to harness the power of inhaled drug delivery to improve patient access to important therapies and develop treatment options for serious diseases where therapeutic options are significantly lacking.
