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Quality Assurance
4 months ago
II. QUALIFICATIONS
• At minimum, completion of a Bachelor’s of Science degree or recognized equivalent • Experience in some or all of Oncology, Clinical Trials, Good Clinical Practice, Quality Control/Assurance, Regulatory Affairs involving human subjects, preferred • Experience in CTA including Preparation of Module 2, IND, ITA submissions preferred • Good written and verbal communication skills, excellent organization, prioritization skills, excellent computer skills and the ability to learn quickly • Ability to work under pressure and attention to detail • Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadlines in accordance to Ozmosis Research Inc. standards • Possess good critical thinking skills with the ability to multi-task • Ability to work well as part of a team • Relevant knowledge of Health Canada and FDA regulations relating to Clinical Trials
III. KEY ACCOUNTABILITIES & RESPONSIBILITIES
• Prepare and submit regulatory submissions (ex: CTA, CTA-A, CTA-N) to Health Canada and FDA according to regulatory requirements • Liaise with regulatory authorities and internally to ensure that any requests for clarifications are responded to within the required timelines • Assist with preparation for any regulatory meetings (ex: pre-CTA meetings) • Perform quality control reviews and audits, communicate results to staff, SDQARA, other members of Senior Management and oversee all reports through to resolution • Support the development and maintenance of tools, trackers, and documents relating to Regulatory Affairs, QC/QA including but not limited to the Master CAPA logs, SOP deviation logs, Internal Audit Tracking, etc. • Support the maintenance of the eTMF index, plans, guidelines and other templates and coordinate eTMF issues between internal staff and vendor • Responsible for the maintenance of SOP revisions, approvals and other documentation • Responsible for the maintenance of Document Control documents and process • Responsible for the maintenance of training documents, organizing training sessions for Ozmosis staff and assist with training on QA and Regulatory topics. • Provide assistance to the SDQARA with metrics analysis, internal audits, preparation of external audits, vendor audits, site audits and writing of audit reports • Contributing to applicable Ozmosis SOPs, documents, and guidelines Other accountabilities and responsibilities may be required depending on business needs.
Ozmosis Research Inc. provides benefits, a generous pension plan and competitive salary that commensurate with experience and skills. Thank you to all applicants for your interest. Only selected applicants will be contacted.
