QA Documentation Specialist

Summary:
A QA Documentation Specialist is require for a biopharmaceutical company in Carlow. The successful candidate will responsible for supporting the Quality Department in the management of the site GMP documentation, and in supporting the Quality functions in various administrative duties.

Responsibilities:

• Ensure that objectives are effectively achieved, consistent with our client’s requirements to ensure Compliance, safety and reliable supply to their customers.
• Responsible for the control, operation and maintenance of the site Central Documentation Control system.
• Be a document system expert; this will include document, review, approval and document system work flow oversight. e.g. SOP’s, work instructions, master forms etc. Support documentation generation, review and approval in line with the standard approval process.
• Support site activities through maintenance/ monitoring of associated databases including MEDS, Quality Docs etc.
• Establish and effectively manage information management systems, develop reports, presentation, projects, timelines and correspondence utilizing many different computerized systems when and if required .
• Use standard systems including MS Word, Excel, PowerPoint, Outlook and various company and industry specific software.
• Issuance and reconciliation of controlled documents to support site activities.
• Support department/site to be audit ready.
• Facilitate site wide awareness of GMP activities; may be facilitated by means such as effective use of communication forums, development and facilitation of training programmes.
• Coordinate & manage special projects within the area/division.. Complete department specific assignments; including SOP administration; coordination of training, GMP Document Tracking; information repository coordination and compliance etc as required.
• Support continuous improvement by active participation in investigations and investigation reports, execution/development of change control, and contribution to Kaizen events and projects as appropriate.
• Required to comply with their Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
• Work collaboratively to drive a safe and compliant culture on site.
• May be required to perform other duties as assigned.

Qualifications & Experience:

• Diploma preferred; ideally in a related discipline.
• Experience and/or a particular skill set in their area of expertise that adds value to the Business, ideally in a manufacturing, preferably GMP setting.
• Proficiency in Microsoft Office and job related computer applications required.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
• Report, standards, policy writing skills required.
• Understanding of Lean Six Sigma Methodology preferred.