Technical Writer
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Job Location:
Yearly Salary:
Posted on:
2 days ago
Vacancies:
1 Vacancy
Job Summary
Benefits:
- Gym Access
- Dental insurance
- Health insurance
Were Hiring!
The Technical Writer reporting to Director of Technical Services is responsible for authoring reviewing and maintaining accurate clear and compliant technical documentation to support Apollo Health and Beauty Cares research development technology transfer and commercial manufacturing activities. This role plays a critical part in ensuring that R&D outputs are well documented scientifically justified traceable and audit ready in accordance with internal Quality Management System (QMS) requirements and applicable regulatory expectations.
The position requires an experienced technical writer with demonstrated expertise in the North American (FDA & Canada) cosmetic OTC and natural products industry capable of independently preparing complex investigation reports risk assessments and change control documentation supporting laboratory development through to commercial batch production.
JOB RESPONSIBILITIES
JOB RESPONSIBILITIES
Investigations Root Cause Analysis & CAPA
- Author and manage technical investigation reports related to deviations OOS and OOT results.
- Facilitate and document Root Cause Analysis (RCA) using structured methodologies (e.g. 5 Whys Fishbone).
- Draft and support Corrective and Preventive Action (CAPA) documentation in collaboration with R&D Quality Assurance and Manufacturing.
R&D Impact & Risk Assessments
- Prepare R&D Impact Assessments evaluating the effect of changes and/or deviations on product quality safety performance and regulatory compliance.
- Prepare R&D Risk Assessments related to formulations processes equipment raw materials and scaleup activities.
Raw Material Assessments
- Develop and maintain Raw Material Assessments supporting cosmetic OTC and natural products.
- Support raw material change evaluations and supplierrelated documentation as required.
Change Control & Technical Transfer
- Generate Change Control documentation to support R&D activities including formulation changes process changes equipment changes and scaleup activities.
- Generate technical documentation supporting transfer of R&D developed products to commercial manufacturing.
Technical Documentation & SOPs
- Draft review edit and maintain Standard Operating Procedures (SOPs) test methods and technical reports.
- Ensure accuracy consistency formatting and version control of R&D documentation.
- Support continuous improvement initiatives related to documentation processes and controls.
CrossFunctional Collaboration
- Work closely with R&D Scientists Product Development Quality Assurance Manufacturing and Regulatory teams to capture technical information accurately.
- Translate complex scientific and technical data into clear professional documentation.
Other Duties
- Perform other duties as assigned by the Director Technical Services in support of departmental and organizational goals.
JOB REQUIREMENTS
- Bachelors degree in chemistry Cosmetic Science Pharmaceutical Sciences Biology or a related scientific discipline.
- Minimum 35 years of technical writing experience within the North American (USA & Canada) OTC cosmetic and/or natural products industry.
- Proven experience authoring investigation reports RCA documentation R&D Impact Assessments R&D Risk Assessments Raw Material Assessments Change Controls and technical transfer documentation.
- Strong understanding of cGMPregulated manufacturing environments.
- Working knowledge of Health Canada and FDA regulatory expectations for OTC and cosmetic products.
- Proficiency in Microsoft Office applications (Word Excel PowerPoint); experience with electronic QMS systems is an asset.
- Exceptional attention to detail and strong command of written English.
- Strong analytical organizational and timemanagement skills.
Apollo Health & Beauty Care Ltd. will ensure accommodations are available in consultation with candidates during all stages of the recruitment process. The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to this job. Duties outlined in this job description may not be all-inclusive and can be modified at any time if requested by management. Apollo is committed to providing accommodations for people with disabilities in all parts of the hiring process. Apollo will work with applicants to meet accommodation needs that are made known in advance.
We thank all applicants for their interest however only those meeting the minimum qualifications will be interviewed.
Vacancy Status: This posting represents an existing vacancy and we are actively recruiting to fill this position.
Vacancy Status: This posting represents an existing vacancy and we are actively recruiting to fill this position.
Compensation: $65000.00 - $75000.00 per year
About Company
Apollo Health And Beauty Care As a leader in its industry, Apollo has been recognized as one of Canada’s 50 Best Managed Companies 12 years in a row, proudly employing over 600 people in the community. For 22 years, Apollo empowered hundreds of retailers of all sizes, thousands of sup ... View more
