QA Regulatory Affairs Specialist
Company: Randstad Life Sciences
Posted on: May 14, 2022
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
Will also support quality assurance functions as needed
ESSENTIAL DUTIES AND RESPONSIBILITIES
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
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
Communicate effectively with regulatory agencies is support of
Communicate effectively with in-country agents for regulatory
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
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
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
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
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
Effectively communicates with supervisor and team members and other
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
Didn't find what you're looking for? Search again!