Compliance Documentation Specialist

Hiring: Compliance Documentation Specialist

Location: Bangalore / Hyderabad

Experience: 5+ Years

We are looking for an experienced Compliance Documentation Specialist with strong technical writing, document control, and quality compliance experience to support documentation governance in a regulated environment.

Key Responsibilities

• Create, review, update, and maintain controlled documents, including SOPs, policies, standards, work instructions, templates, and compliance records.
• Manage document lifecycle activities, including review, approval workflows, version control, change management, and periodic reviews.
• Ensure compliance with Good Documentation Practices (GDP), Quality Management System (QMS) requirements, and organizational standards.
• Collaborate with Quality, Compliance, Engineering, Information Security, and other stakeholders to maintain accurate, audit-ready documentation.
• Maintain controlled document repositories and support internal and external audits.
• Ensure documentation accuracy, traceability, confidentiality, and adherence to governance standards.

Required Skills

• 5+ years of experience in compliance documentation, document control, quality systems, validation, governance, or regulated environments.
• Strong experience authoring and managing SOPs, policies, work instructions, and controlled documents.
• Knowledge of document lifecycle management, change control, version management, and approval processes.
• Working knowledge of SDLC concepts.
• Proficiency in Microsoft Office, SharePoint, and document management systems.
• Excellent technical writing, editing, and stakeholder communication skills.

Good to Have

• Exposure to QMS, ISMS, GxP, CSV, CSA, or Software Quality.
• Knowledge of ISO 9001:2015 and/or ISO/IEC 27001.
• Experience supporting audits, risk assessments, and traceability frameworks.
• Relevant quality, compliance, validation, or auditing certifications.