Job Description

Technical Writer – Compounding

Petersfield

6 Month Fixed term Contract

8.15am – 16.30pm Monday - Friday

Overview:

The Technical Writer in compounding is responsible for producing clear, accurate, and compliant technical documentation to support safe, efficient, and compliant compounding operations at my clients laboratories.

This role provides dedicated ownership of compounding-related documentation, including investigation write-ups, SOPs, and Work Instructions (WKIs), ensuring alignment with GMP, GDP, and site quality standards. The role acts as a critical interface between Compounding, Quality and Technical Support, translating complex manufacturing processes and investigations into robust, inspection-ready documentation.

Key Responsibilities:

Investigation & Deviation Documentation • Author and structure deviation investigations, root cause analyses, and CAPA write-ups related to compounding activities, working closely with Compounding, QA, and TSO.

• Ensure investigations are fact-based, concise, and compliant with Quality SOPs and regulatory expectations

• Support timely closure of investigations by simplifying technical narratives and ensuring clear linkage between root cause, impact, and corrective actions

• Review investigation documentation for GDP compliance, clarity, and audit readiness

SOP & Work Instruction Development

• Write, revise, and maintain Compounding SOPs and WKIs, ensuring consistency with approved templates and document control requirements.

• Translate operational practices into clear, operator-friendly instructions suitable for use on the manufacturing floor

• Partner with Subject Matter Experts (SMEs) to ensure documentation accurately reflects current processes, equipment, and systems

• Support change management by updating documentation in line with process changes, investigations, audit actions, or system updates

Documentation Governance & Compliance

• Ensure all documentation meets GMP and GDP standards, including clarity, traceability, version control, and training impact assessment.

• Support audit and inspection readiness by maintaining well-structured, valid documentation

• Identify gaps, inconsistencies, or risks in existing documentation and proactively drive improvements

• Align compounding documentation with site Quality and Document Management

requirements

Cross-Functional Collaboration & Training Support

• Act as a key documentation interface between Compounding, Quality and Technical Support

• Support training effectiveness by ensuring SOPs and WKIs are fit for purpose, unambiguous, and aligned to how work is physically performed.

• Provide guidance to SME authors and reviewers on best practices for technical writing and compliant documentation

Qualifications/ Experience:

• Proven experience as a Technical Writer or similar role in a GMP-regulated manufacturing environment / or suitable background in report writing (e.g. science degree).

• Strong experience writing SOPs, WKIs, and investigation documentation, or proven ability to translate complex scientific content into clear, accessible documentation for non-specialist audiences

• Solid understanding of GMP / GDP principles and regulatory expectations

• Ability to translate complex technical and operational information into clear, structured documentation

• High attention to detail with a strong quality and compliance mindset

• Strong stakeholder management and collaboration skills

• Experience within pharmaceutical, cosmetics, or regulated manufacturing compounding operations is desirable

• Familiarity with deviation, CAPA, and investigation systems is desirable

• Experience supporting regulatory inspections or audits is desirable

• Knowledge of document management systems and controlled documentation lifecycle