GMP-CQ Technical Writer: Documentation & Compliance Lead

Baker Finn Recruitment; Cork; On-site; EUR 60,000 - 80,000; Full time

Job summary

Baker Finn Recruitment seeks an experienced Commissioning & Qualification (C&Q) Technical Writer to support GMP-regulated facilities across Ireland. The role focuses on preparing, reviewing and maintaining C&Q documentation to ensure installations are properly commissioned and remain in a qualified state.

You will collaborate with Project Engineering, Maintenance, Operations and external contractors, develop procedures and templates, and ensure compliance with GMP, ISPE guidelines and site

Qualifications

• Proven experience in C&Q technical writing within a GMP-regulated environment.
• Track record of supporting GMP facilities and Commissioning & Qualification projects.
• Strong technical writing, documentation and computer skills.

Responsibilities

• Prepare, review and update C&Q documentation in accordance with approved templates, site procedures and regulatory requirements.
• Develop and maintain C&Q procedures, templates, standards and documentation processes to ensure consistency and efficiency.
• Prepare demolition, mechanical completion, Installation Verification (IV) and Operational Verification (OV) documentation.
• Develop and maintain risk assessments, Commissioning & Qualification Plans, Verification Plans, summary reports and User Requirements (UR) documentation.
• Ensure all C&Q documentation complies with GMP and ISPE guidelines.
• Ensure C&Q protocols are executed in the correct sequence and closed out within agreed timelines.
• Provide day-to-day technical guidance to protocol executors and support the resolution of protocol-related queries.
• Register, track and manage discrepancies, following up on outstanding items through to closure.
• Represent the C&Q function on project teams, advising on C&Q requirements, documentation standards and project deliverables.
• Review engineering and C&Q documentation, providing guidance and coaching to technical staff on C&Q processes.
• Ensure personnel involved in C&Q activities are appropriately trained in relevant procedures and documentation requirements.
• Support the delivery of C&Q training courses as required.
• Update and maintain technical data within the Engineering Data Management System (EDMS).
• Coordinate the transfer of completed C&Q documentation into the site document library.
• Maintain C&Q databases to ensure documentation and qualification status are accurate and up to date.
• Support other GMP activities as required, including requalification protocols and Performance Qualification (PQ).
• Participate in and support internal, corporate and third-party audits as assigned.

Skills

C&Q writing

GMP environment

Documentation management

Regulus system

Interpersonal skills

Project collaboration

Attention to detail

Education

Engineering/Science degree

Tools

EDMS

Documentation databases

Job description

Baker Finn Recruitment seeks an experienced Commissioning & Qualification (C&Q) Technical Writer to support GMP-regulated facilities across Ireland. The role focuses on preparing, reviewing and maintaining C&Q documentation to ensure installations are properly commissioned and remain in a qualified state.

You will collaborate with Project Engineering, Maintenance, Operations and external contractors, develop procedures and templates, and ensure compliance with GMP, ISPE guidelines and site