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.
- 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.
- 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.