Pharma Regulatory & Quality Compliance Specialist

Integrated Services for Productivity & Validation, Inc; Barceloneta (PR); Sur place; USD 75 000 - 115 000; Plein temps

Résumé du poste

Integrated Services For Productivity & Validation, Inc in Barceloneta, Puerto Rico, seeks a Regulatory / Compliance Specialist for contract work. The role covers regulatory documentation, cGMP compliance, site transfers, and process qualifications.

The candidate will support Change Control, CAPAs, investigations and environmental guidelines, with 2+ years in regulatory roles and familiarity with CFR 21 and FDA/EU regulations. Requires flexibility for extended shifts.

Qualifications

• 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.

Responsabilités

• Develop, review and/or approve PQR, DMF or other regulatory documents to assure compliance.
• Ensure PQR aligns with site schedule and regulatory due dates.
• Act as Quality representative in site projects (new product introductions/site transfer).
• Support qualification activities across site areas (equipment, process validation).
• Support completion of Change Control documents.
• Evaluate exceptions or investigations and participate in timely resolutions.
• Comply with environmental guidelines, training, and internal notifications of environmental events.
• Perform other assignments related to Quality Operations as required.

Connaissances

Regulatory compliance

CFR 21 knowledge

Communication to all levels

Ability to work with minimal supervis

Formation

Bachelor's degree in science

Outils

SAP

Trackwise

Description du poste

Integrated Services For Productivity & Validation, Inc in Barceloneta, Puerto Rico, seeks a Regulatory / Compliance Specialist for contract work. The role covers regulatory documentation, cGMP compliance, site transfers, and process qualifications.

The candidate will support Change Control, CAPAs, investigations and environmental guidelines, with 2+ years in regulatory roles and familiarity with CFR 21 and FDA/EU regulations. Requires flexibility for extended shifts.