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Regulatory Project Manager

confidential

Chicago, IL

Posted 1 month ago

Messina Group seeks a Regulatory Project Manager

Summary:
Advise and provide hands-on support, to bring the site's quality and IT systems up to the standard required under Q7 to meet FDA compliance for a bulk active pharmaceutical ingredient (API), for the vegetable kosher USP excipient glycerin line.
The project is expected to take about 12 months from sanction to completion. Key elements of the project are:

  • Being involved in the initial stages of the project to establish the timeline based on sound consideration of the tasks to be completed
  • Documentation realignment, in the existing electronic system, and gap-filling to meet Q7 standards while maintaining ISO 9000 and 22000 requirements.
  • Training to meet these standards and practices, and auditing against these.
  • IT existing system validations and improvements, and solutions for compliance for the legacy systems should that not be possible.
  • The setting up a packaging facility for drums and totes to meet FDA standards within the overall project timeframe.
  • Capital cost estimates for the project to meet API compliance for the plant and QC Lab.

Essential Duties and Responsibilities:

  • To provide hands-on support and advice to establish then meet the project aims and timescale for successful completion.
  • To work with all departments and a QA specialist in updating QMS documentation from SOPs, WI, and forms to meet the requirements of Q7 while maintaining the ISO 9000 and 22000 standards.
  • To oversee, prepare and deliver training materials to bring all involved with API glycerine up to the standard required to meet Q7 in a timely manner.
  • To provide QA support for the implementation of the systems and audit the results.
  • To review current IT systems and define what must be done to validate these to meet Q7 standards within the time frame of the project and help achieve this.
  • To work with Supply Chain to define what is needed in a packaging facility and help ensure that is delivered in a timely way.
  • To support any other parts of the project as needed to meet the timeframe.

 

Other Details:

  • Schedule:   8-5
  • Location:  Chicago
  • Duration:  9 months
Contact the Recruiter:
Tracy Vistine Headshot
Tracy Vistine
VP of Talent Acquisition
Tracy Vistine Headshot
Tracy Vistine
VP of Talent Acquisition
tvistine@messinagroupinc.com
847-993-5850
847-993-5850
tvistine@messinagroupinc.com
Messina Group is an Equal Opportunity Employer
We provide and promote equal employment opportunities without regard to race, color, religion, age, sex, national origin, disability status, genetics, veteran status, sexual orientation, gender identity or expression.
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Regulatory Project Manager

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