Crest Solutions have an opportunity for a QA Documentation Specialist to join our team and work on our customer site. The Documentation Specialist will provide compliant, accurate and timely documentation support to the Quality team.

What We Do

Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

Responsibilities and Tasks

• Accountable for the smooth execution of all appropriate documentation associated within QA.
• Contribute to the High Performance culture within the Quality Team by providing a flexible, accurate service to enable them to achieve key priorities. 
• Be an active member of the cross functional QA Team, providing support, guidance and expertise to ensure the success of the Quality Department. 
• Participate and comply with the Quality Management System (QMS) requirements, including ownership, as relevant.
• Update of procedural documents.
• Prepare change control documentation.
• Process documentation through the Change Control System.
• Review of batch records and recording of incidences of corrections made to batch records; generation and control of protocols.
• Coaching others by sharing their skill-set and expertise.

• 3+ years’ experience in the Pharmaceutical industry or a similar operating environment.
• Minimum Leaving Certificate with a requirement to advance to a relevant 3 Level Qualification (Science, Engineering, Quality, Production) within a three year period.
• Demonstrated knowledge of the requirements for entries and completion of batch records.
• Knowledge and experience of GMP and GDP in a pharmaceutical environment.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Manufacturing, Quality, Engineering, Tech Services etc).
• High level technical writing skills.
• Demonstrated ability to realize improvement initiatives.
• Demonstrated successes in a team environment, such as project teams, Six Sigma team, PITs etc.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Stakeholder management of multi decision makers, colleagues, peers and cross functional teams.
• Knowledge of and experience in applying Lean Six Sigma and Lean methodologies.