Manufacturing Compliance Specialist

NOVOCOL PHARMACEUTICAL OF CANADA; Cambridge; On-site; CAD 70,000 - 100,000; Full time

Job summary

Septodont in Cambridge, Canada seeks a Quality Investigator to lead deviation investigations and CAPA activities. You will follow established procedures, apply root cause analysis, and collaborate with QA, RA, Validation, and Production teams to drive timely corrective actions.

The ideal candidate has a university degree in a related science, at least 3 years in pharma QA/QC, and strong technical writing capabilities. Knowledge of GMP and ERP systems is required.

Qualifications

• University degree in a related science.
• Minimum 3 years' experience in the pharmaceutical industry, Quality Engineering or QA/QC.
• Strong proficiency in root cause analysis and corrective actions.
• Excellent technical writing and cross-functional facilitation skills.
• Knowledge of GMP and ERP systems; proficient with Word/Excel.

Responsibilities

• Conduct investigations for deviations following existing procedures.
• Identify critical path for investigations leading to root cause and CAPA.
• Ensure investigations are issued, tasks assigned, and closed timely.
• Facilitate deviations with QA, RA, Validation, Production, and SMEs.
• Use problem-solving tools to identify root causes.
• Provide on-floor support for problem solving and root cause analysis.
• Write and review investigation reports for completeness and accuracy prior to approval by Department Manager.
• Perform impact analysis of proposed corrective and preventative actions.
• Discuss findings with impacted departments and prepare recommendations for Department Managers.
• Prepare and maintain lists of open investigations for Cambridge management.
• Review ongoing progress with Production Management to ensure alignment.
• Facilitate weekly deviation huddle and support KPIs.
• Project manage CAPAs and assist in implementation and follow-up.

Skills

Project management

Root Cause Analysis

Corrective Action Tools

Technical writing

Education

University Degree in a related science

Tools

Word

Excel

ERP systems

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 procedure
• Ensure 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-ongoing 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

• Education University Degree in a related science.
• Experience A minimum of 3 years’ experience in the pharmaceutical industry, Quality Engineering or QA/QC
• Fluency in project management & , Root Cause Analysis and Corrective Action Tools
• Superb technical writing skills and abilities
• Facilitating cross functional teams
• Superior organizational, interpersonal communication skills
• Ability to manage time effectively
• Ability to work independently and manage multiple priorities in a fast-paced and changing environment
• Good command of the English language, both written and verbal
• Critical thinking skills with ability to problem solve
• Knowledge of GMP
• Proficiency with Word, Excel, and ERP systems

WORKING 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 documents Regular visual concentration Level of Work – Light Light 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.

About Septodont

Septodont is a global leader in the development, manufacturing, and distribution of innovative dental pharmaceuticals and medical solutions. With 8 manufacturing plants on 3 continents, and an international distribution network serving professionals in more than 120 countries, we are committed to improving patient care globally. Supported by 4 R&D centers and more than 120 patents registered worldwide, our relentless commitment to innovation and industrial excellence keeps us at the forefront of our industry. As a socially responsible employer, we believe our responsibility is to conduct business with rigor, ethics, and fairness. But our role extends far beyond the products we deliver. Caring also means committing — to our people, our customers and patients, the communities where we operate, and the planet we all share. Learn more about Septodont

Our people make the difference Behind our global success are more than 2,600 dedicated employees whose expertise, commitment, and collaboration power our growth every day. At Septodont, every role matters and every contribution counts. We foster an environment where individuals are empowered to take initiative, share ideas, and grow professionally. Through continuous learning programs, skills development initiatives, and internal mobility opportunities, we actively support our employees in building meaningful and evolving careers.

Want to learn more about our people and how we support them? Discover more here

Why join us?

At Septodont, we share a common ambition: to sustainably improve patient care through safe, effective, and innovative solutions. By joining us, you will:

• Help shape solutions that improve patients’ lives every day.
• Grow within an international and multicultural environment.
• Be part of a company driven by innovation, quality, and strong values.

If you are looking for a career where your expertise truly matters and your work has purpose, Septodont is the place for you.

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