Technical Writer
Charlottetown, PE, Canada
Job Description
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Technical Writer
Charlottetown, PE, Canada Req #1165
Date Posted: March 11, 2023 BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents. BIOVECTRA Inc. has an opening for a Technical Writer. This is a permanent, full-time position located in Charlottetown, PEI. The candidate will be responsible for:
- Writing and managing the change control of technical documents that directly support manufacturing and special projects.
- Working with the project team in identifying specifications and requirements for materials/equipment destined for use in the manufacture of APIs.
- Ensuring documentation is in place for management of receipt, traceability and compliance under cGMP guidelines.
- Consulting and communicating with suppliers and external sales reps concerning the technical details of the scope of service or deliverable and aligning internal documents accordingly through new document creation or change control.
- Preparing validation protocols, associated reports, and other documentation required to support the successful execution of projects.
- Providing training to manufacturing employees and conducting orientation for new employees in standard operating procedures and technical process procedures.
- Facilitating continuous improvement and best practice development within the Production unit.
- Preparing spreadsheets to track critical project data, preparing summary reports, and identifying process improvement opportunities using statistical methods.
- Working with the project team in the identification of instruments, equipment and process aids for the maintenance and manufacturing departments for the Facility and recommending supplier options.
- Tracking training compliance of manufacturing staff to ensure all staff are current with training.
- Providing administrative support for the facility staff and sourcing, purchasing, negotiating equipment and process aids for API processes.
- Adhering to BIOVECTRA\'s Health and Safety Policy as outline in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities.
- Additional duties assigned, based on business needs and the department manager\'s request.
- Postsecondary education in technology, science, or related field.
- Two (2) years\' experience working in the pharmaceutical industry.
- Familiarity with Q7A "Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients" and the ability to apply the Q7A guidance to project requirements is desired.
- One year of technical writing experience considered an asset.
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Job Detail
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Job IdJD2127796
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationCharlottetown, PE, Canada
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EducationNot mentioned