Quality System Specialist
Posted 1 week ago by SRG
Negotiable
Undetermined
Remote
United Kingdom
Summary: The Quality System Specialist role focuses on managing document control processes within a GMP-regulated pharmaceutical manufacturing environment. The candidate will oversee document workflows, support system migration to Veeva Vault, and provide end-user support across various departments. This position requires a detail-oriented individual with experience in pharmaceutical document control. The role is remote and emphasizes collaboration with QA and IT to ensure compliance and optimize workflows.
Key Responsibilities:
- Oversee the full document lifecycle for global SOPs, work instructions, and protocols
- Act as global DMS coordinator, managing ownership, metadata, access, and workflows
- Track and report on periodic reviews, escalating overdue items as needed
- Coordinate translations to ensure timely implementation across global sites
- Provide user support, training, and troubleshooting for DMS users
- Collaborate with QA and IT to optimize workflows and maintain regulatory compliance
Key Skills:
- Bachelor’s degree in Life Sciences, Quality, or a related field (or equivalent experience)
- 3+ years of document control experience in a GMP pharmaceutical setting
- Proficient in DMS (D2) or similar systems
- Strong knowledge of GMP documentation standards and 21 CFR Part 11 / EU Annex 11
- Excellent organizational, communication, and time management skills
Salary (Rate): undetermined
City: undetermined
Country: United Kingdom
Working Arrangements: remote
IR35 Status: undetermined
Seniority Level: undetermined
Industry: Other
Job Title: System Specialist – Document Management (Pharmaceutical Manufacturing)
Location: Remote
We are seeking a detail-oriented Quality System Specialist to support document control processes within a GMP-regulated pharmaceutical manufacturing environment. The successful candidate will manage document workflows, support DMS cleanup ahead of a system migration to Veeva Vault, and provide end-user support across departments.
Key Responsibilities:
- Oversee the full document lifecycle for global SOPs, work instructions, and protocols
- Act as global DMS coordinator, managing ownership, metadata, access, and workflows
- Track and report on periodic reviews, escalating overdue items as needed
- Coordinate translations to ensure timely implementation across global sites
- Provide user support, training, and troubleshooting for DMS users
- Collaborate with QA and IT to optimize workflows and maintain regulatory compliance
Requirements:
- Bachelor’s degree in Life Sciences, Quality, or a related field (or equivalent experience)
- 3+ years of document control experience in a GMP pharmaceutical setting
- Proficient in DMS (D2) or similar systems
- Strong knowledge of GMP documentation standards and 21 CFR Part 11 / EU Annex 11
- Excellent organizational, communication, and time management skills
If you have experience in pharmaceutical document control and are confident supporting DMS operations during transition and transformation projects, we encourage you to apply!