Quality Engineer

The Documentation Quality Engineer is responsible for managing and updating quality system and product life cycle documentation in support of pharmaceutical manufacturing operations. This role ensures all documentation is accurate, current, and compliant with applicable regulatory requirements, including FDA cGMP, ICH guidelines, and internal SOPs. The position plays a critical role in maintaining a robust quality management system (QMS) and supporting regulatory inspections, audits, and continuous improvement initiatives.

Key Responsibilities

Review, revise, and author quality-related documentation, including but not limited to:

Product and process specifications

SOPs, work instructions, and batch records

Validation protocols and reports (IQ/OQ/PQ)

Equipment and utility qualification documents

Change control documentation

Risk assessments and FMEAs

CAPA and deviation documentation

Ensure documentation aligns with current Good Manufacturing Practices (cGMP), ICH Q8-Q10, and internal quality policies.

Maintain and manage the document control process and support lifecycle management activities for new and legacy products.

Coordinate with cross-functional teams (Manufacturing, Engineering, Validation, Regulatory Affairs, and R&D) to gather and verify technical content and ensure timely document updates.

Review documentation for completeness, technical accuracy, clarity, and compliance before approval and issuance.

Support document change requests (DCRs) and change control processes through the electronic Quality Management System (eQMS).

Assist with data gathering and documentation preparation in response to internal audits and external regulatory inspections (FDA, EMA, etc.).

Lead or support document harmonization efforts across departments or sites to ensure consistency and reduce redundancy.

Monitor document effectiveness and participate in continuous improvement initiatives within the quality documentation process. Required Qualifications

Bachelor's degree in Engineering, Life Sciences, Quality, or a related technical discipline.

2-4 years of experience in a pharmaceutical or biotechnology manufacturing environment, preferably in Quality Assurance, Quality Engineering, or Documentation Management.

Solid understanding of FDA 21 CFR Parts 210, 211, and 820, as well as ICH guidelines and other global regulatory standards.

Experience working within a Document Management System (DMS) or electronic Quality Management System (eQMS) such as Veeva, MasterControl, TrackWise, or similar.

Strong technical writing, editing, and document formatting skills.

Ability to interpret engineering drawings, equipment specifications, and validation reports.