Regulatory / Compliance Specialist - Barceloneta

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.