Quality system specialist / technical writer
Detalhes do emprego
Company Overview Proclinical are proud to be partnered with our client, a globally recognized leader in biotherapeutic solutions, dedicated to saving lives and improving the quality of life for people with rare and serious medical conditions. The Tullamarine site is a greenfield ~$1 billion project to establish a state of the art influenza vaccine and antivenom manufacturing site, the only one of it's kind in the southern hemisphere. Job Title: Quality System Specialist / Technical Writer Location: Tullamarine, VIC Start Date: ASAP End Date: 3 months WHV : Yes Capacity: Majority on-site but some work could be done from home. Hours : Mon - Fri standard About the Role: We are seeking a dedicated and detail-oriented Quality System Specialist / Technical Writer to join the Quality Systems team. This role is crucial in developing and evaluating the quality and system procedures to ensure reliability, usability and compliance with company standards and government regulatory requirements. You will be responsible for the writing, review, editing, updating and authorization of various documents including engineering, operations, QA, automation, execution systems, supply chain and warehousing. Key Responsibilities:
- Develops and evaluates quality and system procedures to ensure reliability, usability and compliance with company standards and governmental regulatory requirements.
- Writes procedural documentation including standard operating procedures, work instructions and forms.
- Collaborates with internal teams across departments to interview subject matter experts, determine what type of content is needed, and translates into usable and compliant documentation.
- Responsible for producing high-quality content quickly, and efficiently to ensure deadlines met.
- Edits all content to ensure documentation is created in a user-friendly format, with consistent verbiage, and is clear and concise for the intended audience and in alignment with company templates/requirements.
- For the current project there are 100s of documents to be written.
- Part of the role will require sitting with SMEs to extract information, so there may be some chasing of people for information.
- Bachelor’s degree in Science.
- Must be an experienced technical writer with pharmaceutical and quality system exposure/experience ( ideally 2-5 years of experience in Technical Writing ) .
- Strong attention to detail and excellent organizational skills.
- Must be able to edit all content to ensure documentation is created in a user-friendly format, with consistent verbiage, and is clear and concise for the intended audience and in alignment with company templates/requirements.
- Must have high attention to detail and advanced Word/Excel skills.
- Excellent communication and stakeholder management skills.
- Seeking someone who can help all the different areas with their documentation so seeking someone who has exposure to a number of different areas in pharma (eg engineering, operations, QA, Automation, execution systems, supply chain and warehousing).
- Able to work under pressure and meet project deadlines.
- Exposure to Veeva Q Docs highly regarded.
- Be part of a small, dynamic team within a larger supportive environment.
- Gain valuable experience in supplier management and quality assurance.
- Work in a role that directly impacts the quality and safety of life saving medicines.
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