Quality Assurance Technical Writer

Industry : Excipient Manufacturing

Role Duties & Responsibilities:

  • Lead QA technical documentation projects as an individual contributor.
  • Responsible for the timely completion of projects within the technical writing role.
  • Competent to work independently and manage workload.
  • Collaborate with internal resources and business partners to support project requirements and to ensure project completion.
  • Work in accordance to cGMP and GLP requirements.
  • Ensure consistent and good documentation practices are followed.
  • Creation, review and update of documentation, e.g. Laboratory Technical Protocols and Reports, Standard Operating Procedures and Analytical Protocols.
  • Translate complex topics into clear, concise, understandable topics as required. 
  • Review standards for documentation types, structure, and assembly so that content is organised logically with the end-reader in mind.
  • Actively look for Continuous Improvements. 
  • Maintain documents in the documentation management system.

Role Requirements:

  • Third level qualification (BSc or higher) in Science Related Discipline with previous experience in a pharmaceutical environment.
  • Excellent communication and report writing skills, experienced at communicating complex technical topics.
  • Proven Technical Writing experience in a GMP/Pharmaceutical/Quality environment and understanding of cGMP. 
  • Good PC skills – Word and Excel (essential), Microsoft PowerPoint and Microsoft Projects (desirable).
  • Experience using Quality documentation management systems. 
  • Experience in deviation and investigation writing.
  • Disciplined, deadline-driven and focus on Right First Time. 
  • Responds positively to changing circumstances and priorities.
  • Ability to assimilate technical information from a variety of sources in a timely manner.
  • Proven track record as a Technical Writer is essential.

Skills and Qualifications:

  • Bachelor’s Degree in a Science Related Discipline. 
  • Pharmaceutical/GMP experience a required, knowledge of ISO/IPEC regulations an advantage. 
  • Desired competencies include strong attention to detail focused on delivery of a Quality product. 
  • Good organizational and presentation skills, ability to communicate Quality Metrics to management.
  • Strong interpersonal and communication skills, ability to maintain positive, Quality focused relationship with internal and external stakeholders.

Personal Attributes:

  • Possesses Company values of honesty, integrity, respect, commitment and open to change while modelling the Company Core Principles in all activities
  • Ability to foster collaborative, cross department relationships to meet common objectives.

To apply for this job email your details to enquiries@qaresources.com.