Document Review Specialist

Quanta Consultancy Services Ltd; North Carolina; On-site; USD 60,000 - 90,000; Full time

Job summary

Ein globales Unternehmen in der pharmazeutischen Herstellung sucht einen talentierten Dokumentenprüfer, um das Team zu erweitern. Diese Rolle bietet die Möglichkeit, an einem neuen Produktionsstandort an der Ostküste der Vereinigten Staaten mitzuarbeiten. Der Dokumentenprüfer wird für die Überprüfung von Qualitätssicherungsdokumenten verantwortlich sein und eng mit verschiedenen Abteilungen zusammenarbeiten, um sicherzustellen, dass alle Dokumente den cGMP-Standards entsprechen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Qualifications

• Erfahrung in der Dokumentenprüfung in cGMP-Umgebungen erforderlich.
• Starke Kommunikationsfähigkeiten und Erfahrung im Projektmanagement.

Responsibilities

• Überprüfung von Dokumenten zur Sicherstellung der GDP-Konformität.
• Zusammenarbeit mit CQV-Teams zur Behebung von GDP-Fehlern.

Skills

Dokumentenprüfung

Qualitätssicherung (QA)

cGMP-Standards

Kommunikationsfähigkeiten

Projektmanagement

Tools

KNEAT

Microsoft Office

Job description

Document Review Specialist - US, North Carolina - 6-12 Month Contract

Our client, a global pharmaceutical manufacturing organization, is looking for a talented Document Review Specialist to join their expanding team. With ongoing organizational growth and significant investment across their portfolio and capital programs, this is an exciting opportunity to contribute to their new manufacturing facility on the East Coast of the United States.

Essential Duties and Responsibilities:

1. Read and understand CQV and site quality procedures, aligning with the client's operating principles and regulatory requirements.
2. Work with electronic validation systems such as KNEAT or similar platforms.
3. Conduct GDP reviews of test protocols before and after execution to facilitate timely review and approval with Quality.
4. Utilize and maintain a GDP checklist to track errors in protocols and documents, updating it as needed to ensure comprehensive coverage.
5. Review specifications, design documents, procedures, work instructions, etc., to ensure GDP compliance and proper formatting.
6. Collaborate with CQV Leads, CQV Engineers, and other departments to resolve GDP errors.
7. Train CQV teams on GDP standards.

Requirements:

• Extensive experience in documentation review and/or Quality Assurance roles within cGMP environments.
• Prior experience with cGMP or in highly regulated industries, such as large-scale projects or GMP operational facilities.
• Experience liaising with departments, engineers, and QA teams.
• Strong communication skills and the ability to escalate issues appropriately.
• Proven success managing complex projects in pharma/cGMP settings.
• Proficiency with computer tools like spreadsheets, Word, Visio, and other Microsoft Office applications.

If interested, please apply now for immediate consideration and further information.