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.