QA Document Administrator

PCI Pharma Services; Bridgend; On-site; GBP 25,000 - 35,000; Full time

Job summary

Join a leading pharmaceutical company as a QA Document Administrator. This entry-level role focuses on maintaining controlled documentation and supporting the QA department. You'll manage documents, facilitate audits, and ensure compliance with GxP standards, contributing to life-changing therapies.

Qualifications

• Entry level position focused on QA document administration.
• Requires knowledge of GxP and document management systems.

Responsibilities

• Manage documents within the e-QMS and create new GxP documents.
• Control the issue, distribution, and withdrawal of e-documents.
• Perform general administrative tasks and support client audits.

Skills

Document Management

GxP Compliance

Administrative Support

Job description

Join to apply for the QA Document Administrator role at PCI Pharma Services.

Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

General Purpose of Role

Maintain controlled documentation within the company’s electronic document management system and provide general administrative support to the QA Department.

Main Responsibilities

• Manage documents within the e-QMS
• Create new GxP documents within e-QMS
• Track and facilitate document change requests
• Communicate document review requirements to department managers
• Produce monthly document status reports
• Control the issue, distribution, and withdrawal of e-documents
• Issue documents for training
• Write and author Standard Operating Procedures and instructional documents within scope of duties
• Coordinate scanning and archiving of hardcopy documents
• Manage QA/QP and Client audit calendars
• Support client audit arrangements (as required)
• Administration of batch records for QP review
• Perform general administrative tasks (e.g., travel arrangements, purchase orders, meeting minutes)
• Assist with GMP software validation as required
• Perform other duties as required at job level

Outcomes of Role

• Support the Head of QMS in maintaining controlled documents in line with GxP requirements
• Facilitate document creation and change for site personnel
• Become a subject matter expert for the electronic document management system
• Ensure all hardcopy documents are appropriately controlled and archived

Join us and be part of building the bridge between life-changing therapies and patients. Let’s talk about the future.

Equal Employment Opportunity (EEO) Statement

PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate based on race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, sexual orientation, gender identity or expression, genetics, disability, military status, or other protected statuses.

At PCI, Equity and Inclusion are core to our purpose: delivering life-changing therapies. We are committed to fostering an inclusive workplace through accountability, understanding, fairness, respect, and equal opportunity. We envision a community where everyone belongs and grows, and we strive to realize this by continuously assessing our practices, policies, and culture.

Additional Details

• Seniority level: Entry level
• Employment type: Full-time
• Job function: Information Technology
• Industry: Pharmaceutical Manufacturing