Business Analyst / Technical Writer (Serialization & Traceability)

About Business Platforms:

Headquartered in Cork, Ireland, Business Platforms specialising in Manufacturing Execution Systems (MES), Serialisation, and Supply Chain Operations for our clients.

• We provide consulting services globally to the Pharmaceutical Industry in
• Strategy Development and Execution
• Business Process Analysis and Design
• Change Management
• Validation
• Implementation and Support
• We partner with our clients to provide expertise and industry best practice to create and enable business value.

Role: Business Analyst / Technical Writer (Serialization & Traceability)Location: Hybrid Working can be accommodated 2-3 days per week.

Job Responsibilities

• Business Analyst
• Support GS&T operations and sustainment teams by enabling stable day‑to‑day execution through clear, compliant documentation.
• Contribute to continuous improvement initiatives by identifying documentation gaps, inefficiencies, or opportunities to strengthen GS&T processes.
• Assess and interpret new and evolving global serialization and traceability regulatory requirements, determining potential GS&T impacts.
• Perform impact assessments for business process changes, system enhancements, sustainment activities, and new market or product introductions.
• Support development of mitigation actions and documentation updates to address identified GS&T impacts.
• Coordinate and facilitate discussions with GS&T and business stakeholders to gather information required for documentation development and revision.
• Maintain regular communication with site and global GS&T stakeholders and provide status updates on key documentation and process support activities.
• Technical Writing
• Coordinate and schedule meetings with global serialization stakeholders to collect, analyse, and document business and technical requirements.
• Provide technical writing support for Client’s global serialization programme, with focus on sustainment, operations, aggregation, and regulatory compliance activities.
• Develop, revise, and maintain Standard Operating Procedures (SOPs), Work Instructions, Forms, Business Enabling Documents, and related policies supporting serialization systems and processes aligned with operations/sustainment and project plans.
• Work closely with the serialization team and internal business partners to ensure documentation aligns with defined business processes, regulatory timelines, and compliance requirements.
• Develop and maintain knowledge management artefacts to document serialization operational processes for business analysis, programme management, and organisational change management purposes.
• Progress documentation through Client’s electronic document management system (EDMS) in accordance with internal standards for review, approval, and controlled release.
• Ensure all documentation adheres to Client documentation standards, internal quality systems, and applicable industry best practices.
• Perform all assigned responsibilities in alignment with Client policies, procedures, and project governance expectations.
• Experience
• Strong knowledge of GMP documentation governance within a regulated pharmaceutical or life‑sciences environment.
• Solid understanding of serialization and traceability business processes and associated regulatory expectations.
• Experience working with validated electronic document management systems (e.g. GVault).
• Ability to analyse regulatory and business changes and determine GS&T process and documentation impacts.
• Strong written and verbal communication skills with excellent attention to detail.
• Proven ability to collaborate effectively across site, regional, and global teams.
• Strong organisational and prioritisation skills, with ability to manage multiple operational and sustainment activities concurrently.
• Education:
• Hold a minimum of an Honours Level 8 degree in a Technical/Science/Engineering/ Business Information Systems discipline.
• Remuneration &

Benefits

Business Platforms offers an extremely competitive base salary, commensurate with experience and skill-set.

Great company benefits; medical and dental insurance, life assurance and pension.

Sports & social events.23 days holidays p.a.

At Business Platforms you will work as part of our Global MES Team, working with industry experts. You will be contributing to a variety of unique and challenging projects.

You can expect a positive culture, a collaborative and supportive environment where we encourage new ideas and innovation, to achieve the highest standard of outcomes for our clients.