Technical Writer GxP/GMP Pharmaceutical (REMOTE)

Job details

Job type

Full-time

Full job description

Technical Writer

Remote Across India

6 to 12 months + Contract

We are seeking a detail-oriented and experienced Technical Writer with expertise in Good Manufacturing Practices (GMP) and GxP-compliant documentation, specifically for wiring diagrams, schematics, and installation documentation in a regulated manufacturing environment. The ideal candidate will have a strong understanding of regulated environments and the ability to produce high-quality documentation that meets regulatory and internal standards.

Key Responsibilities:

Create, edit, and maintain wiring diagrams , schematics , installation qualification (IQ) protocols, and system documentation for equipment and facilities in GxP-compliant environments.
Collaborate with Engineering, Validation, QA, and Manufacturing teams to ensure accurate and complete documentation aligned with FDA 21 CFR Part 11 , EU Annex 11 , and GMP guidelines .
Develop and revise Standard Operating Procedures (SOPs) , Work Instructions (WIs) , and technical manuals for electrical and instrumentation systems.
Ensure all documentation meets regulatory, customer, and internal audit requirements.
Review and update legacy documents to meet current compliance standards.
Assist in preparing validation documentation, including FAT, SAT, IQ, OQ protocols and reports.
Maintain document version control in compliance with Document Control systems (e.g., Veeva Vault, MasterControl, or similar).
Participate in audits and provide documentation support during inspections.

Requirements:

Bachelor's degree in Engineering, Technical Writing, Life Sciences, or related field.
3+ years of experience as a Technical Writer in a regulated GxP environment (pharmaceutical, biotech, or medical device).
Strong understanding of GMP regulations , GxP principles , and electrical wiring standards .
Proficiency in creating and interpreting wiring diagrams and technical schematics.
Experience with AutoCAD , EPLAN , or other engineering drawing tools (a plus).
Familiarity with validation lifecycle documentation (URS, IQ, OQ, PQ).
Excellent written and verbal communication skills.
Strong attention to detail and a commitment to documentation accuracy.
Experience with document management systems (e.g., Veeva, Documentum, MasterControl).

Preferred Qualifications:

Knowledge of PLC systems , SCADA , or Client wiring in cleanroom/controlled environments.
Prior experience in FDA-regulated industry audits and documentation remediation.
Certification in Technical Writing or GxP compliance.

Job Type: Full-time

Application Question(s):

How many years of working experience do you have as a Technical Writer in pharmaceutical or biotech company?
Do you have working knowledge of Gxp / GmP compliances?
This is a contract (remote) 6 - 12 month with a possibility of extension. Are you comfortable with this requirement?
What are your salary expectations in INR Gross / month?