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QA Regulatory Affairs Specialist

Company: Randstad Life Sciences
Location: Waukegan
Posted on: May 14, 2022

Job Description:

QA Regulatory Affairs Specialist
Waukegan, Illinois (Must be Onsite)

This position is the primary Quality Assurance/Regulatory Affairs department support for maintaining regulatory submissions
Specific efforts will be the preparation and submission of drug master files (DMF) as well as DMF/ASMF maintenance. This individual will be responsible for the composition of annual product quality reviews for API and Excipient products as required by ICH Q7
This individual will be responsible for providing initial current Good Manufacturing Practice (cGMP) training for all new employees working on site
The individual will also be the primary support for Quality Assurance review of test method and stability protocols and reports
Will also support quality assurance functions as needed

Operate in accordance and compliance with:
Current cGMP regulations and ICH Q7 guidelines
Quality Policies (QP), and Standard Operating Procedures (SOP)
Cardinal Rules of Quality, Delivery and Safety
Drug Master Files (DMF) / Active Substance Master File (ASMF)
Prepare and submit drug master files for submission to applicable regulatory agencies. (i.e. US, Europe, China, etc.)
Maintain the drug master files program via amendments (and annual reports to the FDA or other regulatory agencies as required).
Work with appropriate personnel in response to any possible deficiencies noted by a regulatory agency.
Annual Product Quality Reviews
Prepare annual product quality review reports for API and Excipient products.
Work with appropriate personnel to investigate and resolve any adverse product related issues that may be revealed by the annual product quality review.
Quality Assurance Functions

Support day-to-day quality assurance functions. Including but not limited to:
Communicate effectively with regulatory agencies is support of regulatory submissions
Communicate effectively with in-country agents for regulatory submissions
Communicate effectively with customers when needed
Communicate effectively with internal departments obtain necessary information for regulatory submissions.
Perform second checks for analytical results prior to product release
Review instrument calibration records
Assist colleagues, substitute for colleagues when absent
Write/update standard operating procedures
Assist with audits as requested (i.e. obtaining requested documents)
Participate and lead internal audits of Quality Systems

Bachelor's degree and/or 5+ years regulatory experience in pharmaceutical manufacturing including drug master file preparation, submission, and maintenance experience.
Experience in supervising personnel would be helpful.
Team leadership and project management skills necessary.
Good observation, organization, prioritization, and problem-solving skills.
Working knowledge of the cGMP regulations, FDA and ICH Guidelines, and industry standards.
Experience with global submissions with ASMFs.
Strong working knowledge of drug master files and annual quality reports.
Good computer skills (Database, Word, Excel and Windows based programs associated with compliance tracking).
Strong communication skills (oral and writing strength).
1+ years experience utilizing GlobalSubmit Regulatory Submission software preferred.
Effectively communicates with supervisor and team members and other departments

Must have good hearing and sight - adequate for safety programs in a pharmaceutical manufacturing plant.
Must be able to sit and/or stand for extended periods.
Ability to work effectively under pressure to meet deadlines.
Frequent sitting, standing, walking, climbing of stairs, use of computer monitor screen, talking, writing, listening.
Must be able to lift 50 lbs.

Keywords: Randstad Life Sciences, Waukegan , QA Regulatory Affairs Specialist, Other , Waukegan, Illinois

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