QA Documentation Specialist

Recruiter
Crest Solutions
Employment Type
Contract
Salary
Not disclosed
Crest Solutions logo

Crest Solutions are seeking a QA Documentation Specialist to work in the Label Operations Team in our customer site in Cork

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:

Manages coordination activity for Labelling Operations, specifically as follows:

  • Creates and coordinates approval of documents to support Labelling activities, liaising cross functionally as required
  • Liaises with the print vendors, and across multiple functions to ensure the timely implementation of artwork
  • Creation and update of Commercial Formula for Label Ops, where required.
  • Set up of Artwork Change Order and associated Items for Label Ops, where required.
  • Coordination and creation of Change Control in support of the Labelling Department in Quality Systems.
  • Provides back up to the Data Steward role where required;

o Creation and update of items for all required item types in the applicable system, for 

o Processing all requests for new items, or updates to existing items for 

o Creation and update of Commercial Formula, where required.

o Creation and update of GxP manufacturers 

o Processing all requests for new manufacturers, or updates to existing manufacturers 

o Ensuring all master data adheres to the Data Standard Requirements

o Ensuring all the correct linkages are made between items, manufacturers, commercial formula etc. so that the system generated reports are accurate and correct.

  • Recommends improvements and develops systems / SOPs to enhance the coordinator process
  • Assists in the training of other team members
  • Participates in collaborative projects where required, interactive with internal and external resources.
  • SOP/document management:

o Adheres to SOPs to maintain standards and quality

o Develops SOPs for relatively complex processes

o Participate in the SOP/document management for the wider Labelling Operations team

Skills and Experience Required:

  • 3+ years of relevant experience and associated qualifications.
  • Prior experience in a related industry including experience with product launches & packaging.
  • Excellent verbal, written, and interpersonal communication skills with internal and external customers.
  • Strong computer skills and excellent organizational skills.
  • Proficient in PC environment; MS Office 
  • Possesses a strong knowledge of FDA cGMP standards and regulatory guidance documents.
  • Able to work independently.
  • Demonstrates attention to detail and accuracy.

Why Join Crest Solutions?

At Crest Solutions we understand that our people are our greatest asset. For this reason and many others, we take care of them. The team in Crest Solutions benefits from a Total Rewards package. This includes great personal benefits and professional growth opportunities. An example of what is offered to our team members is as follows: 

  • Competitive salary.
  • Full healthcare cover, leave benefits, life assurance, flexi-time and pension scheme.
  • A varied and exciting career with Crest Solutions with opportunities to work in a cutting-edge, innovative technological environment.
  • A structured approach to professional development opportunities with an educational assistance program