We are seeking a detail-oriented Technical Writer to assist in the cleanup and harmonization of Stability Quality Management System (QMS) documents and Standard Operating Procedures (SOPs) in preparation for the Summit transition. The ideal candidate will have a strong background in technical writing, document management, and regulatory compliance within the pharmaceutical or related industry.
Key Responsibilities:
Stability QMS Document Cleanup:
Review and clean up Stability QMS Standard Operating Procedures (SOPs) post pre-review to ensure readiness for translation.
Collaborate in the creation of Delta Decks to track changes and updates to documentation.
Evaluate local SOPs for potential harmonization opportunities as part of the transition to the Summit system.
Prepare documents by formula to summarize available stability reports for Self-Care and EH formulas, leveraging existing Self-Care documentation to streamline data collection for stability evaluations.
Lab SOP Harmonization:
Lead the harmonization and consolidation of Skillman and FW SOPs in anticipation of the Summit move.
Develop a unified and harmonized procedure that aligns with regulatory standards and organizational practices.
Qualifications:
Bachelor’s degree in a relevant field (e.g., Life Sciences, Technical Writing, Communications).
Proven experience in technical writing and document management, preferably within the pharmaceutical or biotechnology industry.
Strong understanding of Quality Management Systems and regulatory compliance.
Excellent attention to detail and organizational skills.
Ability to work collaboratively with cross-functional teams and communicate effectively with stakeholders.
Familiarity with document preparation software and tools.
Preferred Skills:
Experience in SOP development and management.
Knowledge of stability related documentation processes.
Proficiency in using document management systems and software.
MS Office Suite
This role is critical in ensuring that our Stability QMS documentation is accurate, up-to-date, and compliant with industry standards as we prepare for our transition to the Summit system.
The following disclaimer for CA must be included (remove the equal opportunities wording from the advert template in the bottom paragraph and replace with the following):
ClinChoice Canada Inc. is proud to be an equal opportunity employer, valuing and respecting diversity. We are committed to inclusive, barrier-free recruitment and selection processes. We will accommodate the needs of qualified applicants under the Human Rights Code and the Accessibility for Ontarians Disabilities Act, in all aspects of the hiring process, upon request by calling + 1 (647)724-5709 x 301.
We thank all applicants for their interest; however, only those being considered for an interview will be contacted. In accordance with Federal Personal Information Protection and Electronic Documents Act ("PIPEDA") , personal information is collected under the authority of the Act and will only be used for candidate selection.
