Manufacturing Documentation & Systems Specialist

POSITION SUMMARY

We are seeking a detail-oriented and systems-savvy Manufacturing Documentation & Systems Specialist to support the execution, maintenance, and continuous improvement of manufacturing documentation and digital systems. This role is essential in ensuring compliance with cGMP standards, supporting electronic batch record systems (e.g., PAS-X), and managing documentation workflows that enable efficient and compliant manufacturing operations. The post holder will support the manufacturing team to ensure essential elements are in place to allow operations run to scheduled timelines.

POSITION RESPONSIBILITIES

Documentation Management

• Create, review, and maintain manufacturing documents such as:
• Ensure documents are accurate, up-to-date, and compliant with regulatory and internal standards.
• Coordinate document change control processes in collaboration with Quality Assurance.

Systems Administration & Support

• Act as a superuser or coordinator for digital manufacturing systems, such as:

Compliance & Audit Readiness

• Ensure all documentation and system records are audit-ready and meet GMP and regulatory requirements.
• Support internalandexternal Quality, Safety and Regulatory audits by preparing documentation and responding to data requests.
• Participate in Quality and Safety and Regulatory audits as required.
• Track and implement CAPAs related to documentation or system issues
• Completion of production related SCARs
• Support QA with (MCNs) Material Change Notifications.

Process Improvement

• Identify opportunities to streamline documentation workflows and reduce manual errors.
• Participate in or lead continuous improvement projects related to digital systems and documentation practices.
• Collaborate with cross-functional teams (Manufacturing, GMT, QA, IT, Engineering) to enhance system integration and efficiency.

Training & Communication

• Train manufacturing staff on document control procedures and system usage.
• Assist in the generation of training materials and the execution of training.
• Serve as a liaison between manufacturing, quality, and IT teams to ensure alignment on documentation and system needs.

ORGANIZATIONAL RELATIONSHIPS

This role will include working with teams, both in Zoetis Tullamore and externally with Contract Manufacturing Organisations.

The role will involve interaction with USP, and DSP within the manufacturing department and with external stake holders such as QC, WHSE and ENG.

EDUCATION AND EXPERIENCE

At least 2 years’ experience in a similar role in a corporate environment.

TECHNICAL SKILLS REQUIREMENTS

Technical Skills

• Document Control Systems: Proficiency with electronic document management systems (EDMS), quality management systems (QMS), or ERP platforms.
• Regulatory Knowledge: Understanding of standards like GMP, FDA 21 CFR Part 11, or other industry-specific regulations.
• Data Management: Ability to manage, track, and analyze documentation data and system metrics.
• Software Proficiency: Strong skills in Microsoft Office Suite (especially Word, Excel, and SharePoint).

Analytical & Organizational Skills

• Attention to Detail: Ensuring accuracy and compliance in documentation.
• Process-Oriented Thinking: Ability to map, improve, and streamline documentation workflows.
• Problem-Solving: Identifying and resolving issues in documentation systems or processes.

Interpersonal & Communication Skills

• Collaboration: Working with cross-functional teams including manufacturing, quality, and IT.
• Training & Support: Educating users on documentation systems and best practices.
• Clear Communication: Writing and editing SOPs, work instructions, and reports clearly and concisely.

Time & Project Management

• Multitasking: Managing multiple document revisions and system updates simultaneously.
• Deadline Management: Prioritizing tasks to meet compliance and production timelines.

PHYSICAL POSITION REQUIREMENTS

This will primarily be desk based. There will be a requirement to support out of hours activities on occasion.