Manufacturing Compliance Specialist

Septodont; Cambridge; On-site; CAD 70,000 - 105,000; Full time

Job summary

Novocol Pharmaceutical of Canada Inc. is seeking a Quality Engineer to lead deviation investigations and drive corrective and preventive actions across QA, RA, and Production. The role emphasizes root-cause analysis, documentable problem-solving, and clear technical reporting.

The candidate will manage investigation progress, facilitate weekly huddles, and ensure timely closure of CAPA activities while supporting a fast-paced pharmaceutical environment in Cambridge, Ontario.

Qualifications

• University degree in a related science.
• Experience in pharmaceutical quality engineering or QA/QC is preferred.
• Fluency in project management and root cause analysis tools.
• Strong technical writing skills and ability to communicate across teams.

Responsibilities

• Conducts investigations for deviations following existing procedures.
• Identifies critical path for investigations to identify root cause, corrective & preventative actions.
• Issues investigations and assigns tasks for completion, ensuring timely closure.
• Coordinates with QA, RA, Validation, Production and other SMEs to determine root cause.
• Writes and reviews investigation reports for completeness and accuracy for department approval.
• Performs impact analysis of proposed corrective and preventative actions and communicates recommendations.

Education

University Degree in a related science

Tools

ERP systems

Word

Excel

Job description

PRIMARY DUTIES AND RESPONSIBILITIES:Conducts investigations for deviations following existing procedures.Identifies and/or recognizes critical path for investigations leading to timely identification of root cause, corrective & preventative actions.Ensure investigations are issued; tasks are appropriately assigned for completion or corrective and preventative actions and are closed in a timely fashion.Works to facilitate, coordinate and investigate deviations with the relevant team and Subject Matter Experts (SME) to identify issues and root cause. Utilizes problem solving and root-cause analysis tools to facilitate the investigation.Provides on-floor support, when possible, to assist the team with problem solving and help identify the root cause of issues.Ensure investigations related to Operations are initiated and written as per existing procedureEnsure identification of most probable root cause, corrective action & preventative action for all completed investigations. Writes and reviews investigation reports for completeness and accuracy prior to approval by Department Manager.Conducts impact analysis of proposed corrective & preventative actions. Discuss findings with impacted departments (QA, RA, Validation, Production, etc.) and prepare recommendations for Department Managers.Prepare and maintain lists, including status and next steps of open investigations for Cambridge Management.Review on-going progress on relevant open investigations with Production Management to ensure alignment.Facilitates the weekly deviation huddle and supports the team in achieving established key performance indicators (KPIs).Project manages the corrective and preventative actions and assists in both implementation and follow-up.BASIC REQUIREMENTS:EducationUniversity Degree in a related science.ExperienceA minimum of 3 years’ experience in the pharmaceutical industry, Quality Engineering or QA/QCFluency in project management &, Root Cause Analysis and Corrective Action ToolsSuperb technical writing skills and abilitiesFacilitating cross functional teamsSuperior organizational, interpersonal communication skillsAbility to manage time effectivelyAbility to work independently and manage multiple priorities in a fast-paced and changing environmentGood command of the English language, both written and verbalCritical thinking skills with ability to problem solveKnowledge of GMPProficiency with Word, Excel, and ERP systemsWORKING CONDITIONS:The working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals to perform the essential functions.Perform a variety of ordinary office tasks with light physical exertion such as intermittent walking, standing, sitting, etc.Handling light-weight materials or documentsRegular visual concentrationLevel of Work – LightLight work is defined as exerting up to 9.0 kg of force on an occasional basis (0-33% of the workday), up to 4.5kg of force on a frequent basis (34.66% of the workday) and a negligible amount of force on a constant basis (67-100% of the work day).Work Authorization: Applicants must be legally authorized to work in the country where the position is based for the duration of employment. This position is not eligible for employer-sponsored immigration support.We are committed to diversity and inclusion, and thank all applicants in advance; however, we will be corresponding only with those selected for an interview.In accordance with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act, we are committed to providing an inclusive and barrier free recruitment and selection process.Recruitment Fraud – please be aware of recruitment fraud. Novocol Pharmaceutical of Canada Inc. will never ask for banking information, money or any personal information up front. We will only respond to official applications submitted through our careers site. In addition, we will only use official corporate e-mail addresses (septodont.com or novocolpharma.com) to communicate with applicants. Should you be contacted without submitting an application, please delete the message and advise your e-mail provider.