We are seeking a Technical Writer to join our pharmaceutical startup in Singapore as we establish and commission our manufacturing operations and progress through IOPQ. The successful candidate will play a critical role in building a robust, controlled and inspection-ready documentation system covering GxP documentation, SOPs, URS, qualification/validation documents, work instructions, protocols, reports and other technical documentation.
This is a hands-on role suited to someone who can work closely with QA, Engineering, Manufacturing, Validation, QC and external vendors/consultants, translate technical requirements into clear controlled documents, and ensure documentation is complete, consistent and suitable for a regulated pharmaceutical environment.
Key Responsibilities
1. Pharmaceutical Documentation
- Develop, draft, review and maintain controlled pharmaceutical documentation.
- Prepare and coordinate SOPs, work instructions, forms, templates, protocols and reports.
- Support development of documentation required for facility, equipment, utilities and manufacturing systems.
- Ensure documents are clear, technically accurate, traceable and aligned with approved processes.
- Maintain consistency in terminology, formatting, document numbering and revision control.
- Incorporate comments and feedback from SMEs while maintaining document integrity and version control.
2. URS & Engineering/Qualification Documentation
Support preparation, review and maintenance of:
- User Requirement Specifications (URS)
- Functional/design specifications where required
- Equipment and system specifications
- Risk assessments
- Design review documentation
- FAT/SAT documentation
- IQ/OQ/PQ/IOPQ protocols and reports
- Commissioning and qualification documentation
- Traceability matrices
- Deviation and punch-list documentation
- Change-control documentation
- Validation/qualification summary reports
Work closely with Engineering, Validation and QA SMEs to convert technical input into structured, auditable documentation.
3. SOP Development
- Develop SOPs covering manufacturing, equipment operation, cleaning, maintenance, calibration, documentation practices and other operational processes.
- Interview SMEs and process owners to understand actual workflows.
- Translate technical processes into practical, unambiguous and user-friendly instructions.
- Ensure SOPs appropriately address GMP/GxP expectations, roles and responsibilities, safety, documentation requirements and acceptance criteria.
- Coordinate review, approval, issuance and periodic revision of SOPs.
4. IOPQ / Commissioning Support
As the company progresses through commissioning and qualification:
- Prepare and format qualification protocols and reports.
- Compile technical evidence and supporting documentation.
- Maintain document trackers and status reports.
- Ensure protocol/report content is complete and internally consistent.
- Support closure of documentation-related observations, comments and discrepancies.
- Coordinate inputs from Engineering, Validation, QA, Manufacturing and vendors.
- Maintain traceability between requirements, qualification activities, results and conclusions.
5. Quality & Compliance
- Work within the company's Quality Management System (QMS) and document-control processes.
- Ensure documentation follows applicable GMP/GxP requirements and Good Documentation Practices (GDP).
- Support inspection readiness through accurate, complete and traceable documentation.
- Identify gaps, inconsistencies or missing information and proactively follow up with relevant stakeholders.
- Support document review and remediation activities arising from internal audits, regulatory inspections or quality reviews.
6. Cross-Functional Collaboration
- Work directly with QA, QC, Manufacturing, Engineering, Validation, Automation/IT, Supply Chain and external consultants/vendors.
- Facilitate documentation workshops and SME interviews.
- Clarify technical information and resolve documentation gaps.
- Establish practical documentation standards that can scale as the startup grows.
Required Qualifications & Experience
- Degree or diploma in Technical Writing, Life Sciences, Pharmaceutical Sciences, Engineering, Chemistry, Biotechnology or a related discipline.
- 3–7+ years of technical writing/documentation experience, preferably within pharmaceutical, biotechnology, medical device, chemical manufacturing or another regulated GxP environment.
- Demonstrated experience preparing SOPs, URS, protocols, reports and technical/qualification documentation.
- Understanding of GMP/GxP and Good Documentation Practices.
- Experience working with technical SMEs and converting complex technical information into clear documentation.
- Excellent attention to detail and document-control discipline.
- Ability to manage multiple documents and deadlines in a fast-moving startup environment.
Highly Desirable
- Experience in pharmaceutical manufacturing.
- Experience with IQ/OQ/PQ, IOPQ, FAT/SAT and equipment qualification.
- Familiarity with pharmaceutical facilities, HVAC, purified water, compressed air, process equipment and manufacturing utilities.
- Experience with risk assessments, change controls, deviations/CAPA and validation documentation.
- Familiarity with ALCOA+ principles and data integrity expectations.
- Experience working with equipment suppliers, engineering firms or validation consultants.
