1 Develop, review and/or approval of Product QualityReviews
(PQR), Drug Master Files (DMF) or any other regulatory document to assure
compliance and proper documentation according to product’s corporate policies
and regulatory requirements. Assure PQR comply with site schedule in order to
comply with Regulatory Affairs due date. Compile all information and data
review to evaluate process behavior and determine process capability limits.
Submit PQR to applicable parties.
2 Act as Quality representative in site projects such as new
product introductions/site transfer, providing guidance to all activities
required to assure compliance with cGMP’s.
3 Provide support to the qualification activities for all
areas of the site, including but not limited to:
a. Equipment mechanical and performance qualification
documents.
b. Systems qualification documents.
c. Process validation documents including cleaning
processes.
4 Support completion of Change Control documents.
5 Perform evaluation of exceptions or investigations. Actively
participate in events discussions to assist in a timely resolution, including
OOX, Events, Deviations, Supplier Notifications, CAPAs.
6 Support other documents development and revision such as
batch records and SOP’s if necessary.
7 Comply with all environmental guidelines, procedures,
training, practices, permit conditions, and internal notification of any
environmental events.
8 Will realize other assignments related to Quality
Operations responsibilities, as required.
Requirements
- Bachelor's degree in science (chemistry, biology,
engineering, pharmacy, microbiology, etc.).
- In-depth knowledge of process technology, cGMP’s, safety
and environmental policies.
- 3-5 years of experience in the Pharmaceutical Industry
with at least 2 years as Regulatory / Compliance Specialist
- Willing to work irregular and/or extended shifts if
needed.
- Strong understanding of CFR 21, FDA and EU regulations
among others.
- Microsoft Office applications, SAP, Trackwise and other
programs related to function.
- Ability to work under minimal supervision, thorough
knowledge of plant operations and ability to communicate to all levels of
management.
Skills Required
- Bachelor's degree in science, such as chemistry, biology, engineering, pharmacy, or microbiology
- In-depth knowledge of process technology and cGMP requirements
- Knowledge of safety and environmental policies
- 3-5 years of experience in the pharmaceutical industry
- At least 2 years of experience as a Regulatory or Compliance Specialist
- Willingness to work irregular or extended shifts when needed
- Strong understanding of CFR 21, FDA, and EU regulations
- Proficiency with Microsoft Office, SAP, TrackWise, and other relevant programs
- Ability to work under minimal supervision
- Thorough knowledge of plant operations
- Ability to communicate effectively with all levels of management
What We Do
ISPV Inc. is a Life Science company that leads Productivity & Validation projects for the Pharmaceutical and Food industries.
