OVERALL RESPONSIBILITY

To complete, manage and deliver the suite of documentation and support activities within validation optimization team. The role requires collaboration with Engineering, Quality and Regulatory across DePuy Synthes sites in Ireland and USA.

DUTIES & RESPONSIBILITIES

· Perform technical writing activities and assist the validation optimization team in the generation of all documentations including Procedures/Work Instructions/Forms/Training materials and any other relevant documents as required.

· Update and edit Procedures and Work Instructions, guidance documents, project presentations and reports.

· Manages and monitors the metrics related to document updates.

· Ensure accuracy and consistency across the suite of documentation.

· Completing updates and changes of documents through the PLM system

· Create clear and concise written communications for the business on behalf on project team

· Other ad-hoc duties may include managing and supporting metrics, communications, and project tracking.

EXPERIENCE & EDUCATION

Essential:

· Qualification in an appropriate discipline (e.g. Engineering, Information Systems, or Life Sciences) with a broad technical/educational skills base

· Knowledge of 21 CFR 820, 21 CFR 11 and European regulations associated with medical device industry

· Understanding of GMP, Compliance, Validation Practices including the manufacturing validation life cycle.

Desirable:

· Experience working in a regulated environment would be an advantage.

· Expertise in the use of Microsoft Word, Excel and Power Point and electronic document management systems.

· Excellent verbal and written communication skills

· Excellent interpersonal and team collaboration skills are essential

· Establishes and manages engagement objectives and expectations, Works independently and/or within team to accomplish job objectives.

· Self-Starter

· Establishes and follows priorities

· Suggest and sometimes may implement innovation and continuous improvement within the technical/validation writing process.

· Builds cross functional and cross-departmental support, fostering overall effectiveness

· Demonstrates effective and active listening