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QA Senior Documentation Specialist

Reference:KS/AFVR-555487
Location: Louth
Republic of Ireland
Qualification:Degree
Experience:4-5 Years
Job Type:Permanent
Salary:Not Disclosed
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Our client is a leading provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. They are a global contract development and manufacturing (CDMO) company for biopharmaceuticals; they provide their clients with a world-leading open access technology platform. They enable their clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

They are currently seeking to fill a critical role within the QA organisation, a QA Senior Documentation Specialist who will manage 3 document controllers.

The QA Senior Documentation Specialist will be responsible for documentation generation and the maintenance of documentation systems. Introduction of process improvements associated with the handling of documentation across the site ensuring data integrity requirements are met. Support site level ownership of the Training and Document management system and the archiving of site documentation.

As QA Senior Documentation Specialist, you will be joining an organization where people of all backgrounds and experiences are respected, and where they work together focused on changing lives. In this role you will report to the QMS Lead.

Role/Responsibilities:

Essential duties and responsibilities of this role include and are not limited to the following;

  • Coaching/mentoring, and training for a headcount of approximately 3 people.
  • Maintaining the company GMP paper-based and electronic documentation.
  • Control and distribution of records and overseeing the implementation of quality documents in each department.
  • Maintenance of Electronic and Paper Document Management System through the following:
  1. Issuance and recording of document numbers.
  2. Receive, confirm, and review the final template of document and print the master file for the author.
  3. Maintain templates for GMP documentation.
  • Arrange documents to take effect and inform involved departments and document coordinators.
  • On-site distribution, retrieval, reconciliation, and destruction of controlled documents.
  • Updating and maintaining document directories (general, project and audit).
  • Periodic review of SOPs, preparing the annual review plan, documentation distribution and notifying coordinators of each department.
  • Control and distribution of QC analytical methods and specifications.
  • Be responsible for the use and management of laboratory notebooks.
  • Provide site training on the training management system Master Control.
  • Assist in the drafting, approval and distribution of other quality system documents within the organisation and promote the consistency of quality management.
  • Act as SME for Quality system, updating and reviewing SOPs according to the latest GMP regulation and industry practice.
  • Generate and review change controls and deviations as applicable.
  • Introduce continuous improvements ensuring data integrity requirements are continuously met.
  • Flexibility to take on additional tasks and responsibilities at the discretion of the QMS Lead.
  • Act as a role model for the Quality Organisation – Speak with one quality voice and demonstrate our clients values and behaviours.
Education/Experience:

The ideal candidate for this position, will have the following:

Qualifications:
  • Degree in Biopharmaceutical Science or other related science discipline
Knowledge/Experience:
  • Minimum of 5 years’ experience working in a fast-paced environment with relevant experience in a GMP facility, within Quality, responsible for a documentation management system.
  • Experience in the operation of electronic and paper-based systems for the management of data in a GMP environment including data integrity requirements.
  • Familiar with ICH, EU, FDA and GMP regulations.
  • Demonstrated knowledge of Quality Management System and continuous/process improvement tools.
  • Excellent computer skills MS Office (WORD, EXCEL, PowerPoint)
Behavioural Competencies:
  • Excellent organizational skills, prioritizing abilities, work as part of a cross functional team.
  • Capable of planning ahead to ensure any problems are resolved promptly and accurately.
  • Excellent communication and interpersonal skills.
  • Collaborative and inclusive approach to work and your colleagues.
  • Excellent problem solving and troubleshooting skills.
  • Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
  • Autonomous and a self-starter who will use their initiative to drive actions forward.
  • Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers’ expectation.
For further details please contact:

Karen Shiel on 087 7452487 or send CV to [email protected] in confidence



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