Posted 21 May, 2026
Technical Writer Regulated Digital & Quality Systems
NR Consulting - India
Hyderabad, IN
Full Time
Reference: 26-05214-2220-1
Title: Technical Writer – Regulated Digital & Quality Systems
Location: Hyderabad
Exp: 10 years
Job Description:
Core Responsibilities:
Documentation Development & Ownership
Develop, revise, and maintain controlled documentation including:
• Standard Operating Procedures (SOPs)
• Work Instructions (WI)
• Functional Specifications (FS)
• Design Specifications (DS)
• Validation Documentation (IQ/OQ/PQ)
• User Guides and System Documentation
• Change Control and Process Documentation
• Training and Operational Support Materials
Own documentation quality from draft creation through approval and release.
Regulatory & Compliance Alignment
Ensure all documentation adheres to:
• GxP / GMP standards
• FDA 21 CFR Part 11 requirements
• Data Integrity principles (ALCOA+)
• Internal quality management standards
• Audit and inspection readiness expectations
Support traceability, version control, and controlled document lifecycle processes within validated environments.
Cross-Functional Collaboration
Partner with stakeholders across:
• Manufacturing
• Quality Assurance
• Validation
• Engineering
• IT / Digital Technology
• Automation and System Owners
Facilitate content gathering sessions, challenge ambiguity, validate technical accuracy, and drive alignment on final deliverables.
Documentation Governance & Process Excellence
Drive consistency across documentation standards, templates, terminology, and formatting practices.
Support:
• Document migration initiatives
• Legacy document remediation
• Process harmonization efforts
• Continuous improvement initiatives
• Inspection and audit preparation activities
Maintain high standards for readability, usability, and operational clarity.
Required Qualifications
• Bachelor's degree in Technical Writing, Engineering, Life Sciences, Biotechnology, Quality, or related discipline
• 10+ years of technical writing experience within regulated industries
• Demonstrated experience supporting GMP/GxP environments
• Strong experience authoring:
o SOPs
o Validation documentation
o Controlled quality documentation
o System/process documentation
• Experience working within document management systems such as:
o Veeva
o MasterControl
o TrackWise
o SharePoint
o Comparable QMS/DMS platforms
• Strong understanding of document control principles and change management processes
• Exceptional written communication, editing, and organizational skills
• Ability to manage multiple concurrent deliverables under tight timelines
Preferred Qualifications
• Experience in pharmaceutical, biotechnology, medical device, or healthcare manufacturing environments
• Familiarity with:
o MES
o LIMS
o ERP platforms
o Digital manufacturing ecosystems
• Experience supporting Computer System Validation (CSV) initiatives
• Exposure to Agile, SDLC, or enterprise transformation programs
• Experience with structured authoring tools such as:
o MadCap Flare
o Adobe FrameMaker
o XML/DITA-based environments
• Lean, Six Sigma, or process improvement exposure preferred
Critical Success Indicators
Success in this role will be measured by:
• Audit readiness and documentation compliance
• Reduction in documentation defects and rework
• Timely delivery of controlled documents
• Quality and clarity of technical content
• Stakeholder confidence and adoption
• Documentation traceability and lifecycle accuracy
• Contribution to operational and quality excellence initiatives
Location: Hyderabad
Exp: 10 years
Job Description:
Core Responsibilities:
Documentation Development & Ownership
Develop, revise, and maintain controlled documentation including:
• Standard Operating Procedures (SOPs)
• Work Instructions (WI)
• Functional Specifications (FS)
• Design Specifications (DS)
• Validation Documentation (IQ/OQ/PQ)
• User Guides and System Documentation
• Change Control and Process Documentation
• Training and Operational Support Materials
Own documentation quality from draft creation through approval and release.
Regulatory & Compliance Alignment
Ensure all documentation adheres to:
• GxP / GMP standards
• FDA 21 CFR Part 11 requirements
• Data Integrity principles (ALCOA+)
• Internal quality management standards
• Audit and inspection readiness expectations
Support traceability, version control, and controlled document lifecycle processes within validated environments.
Cross-Functional Collaboration
Partner with stakeholders across:
• Manufacturing
• Quality Assurance
• Validation
• Engineering
• IT / Digital Technology
• Automation and System Owners
Facilitate content gathering sessions, challenge ambiguity, validate technical accuracy, and drive alignment on final deliverables.
Documentation Governance & Process Excellence
Drive consistency across documentation standards, templates, terminology, and formatting practices.
Support:
• Document migration initiatives
• Legacy document remediation
• Process harmonization efforts
• Continuous improvement initiatives
• Inspection and audit preparation activities
Maintain high standards for readability, usability, and operational clarity.
Required Qualifications
• Bachelor's degree in Technical Writing, Engineering, Life Sciences, Biotechnology, Quality, or related discipline
• 10+ years of technical writing experience within regulated industries
• Demonstrated experience supporting GMP/GxP environments
• Strong experience authoring:
o SOPs
o Validation documentation
o Controlled quality documentation
o System/process documentation
• Experience working within document management systems such as:
o Veeva
o MasterControl
o TrackWise
o SharePoint
o Comparable QMS/DMS platforms
• Strong understanding of document control principles and change management processes
• Exceptional written communication, editing, and organizational skills
• Ability to manage multiple concurrent deliverables under tight timelines
Preferred Qualifications
• Experience in pharmaceutical, biotechnology, medical device, or healthcare manufacturing environments
• Familiarity with:
o MES
o LIMS
o ERP platforms
o Digital manufacturing ecosystems
• Experience supporting Computer System Validation (CSV) initiatives
• Exposure to Agile, SDLC, or enterprise transformation programs
• Experience with structured authoring tools such as:
o MadCap Flare
o Adobe FrameMaker
o XML/DITA-based environments
• Lean, Six Sigma, or process improvement exposure preferred
Critical Success Indicators
Success in this role will be measured by:
• Audit readiness and documentation compliance
• Reduction in documentation defects and rework
• Timely delivery of controlled documents
• Quality and clarity of technical content
• Stakeholder confidence and adoption
• Documentation traceability and lifecycle accuracy
• Contribution to operational and quality excellence initiatives
