Manufacturing Compliance Specialist

Septodont; Cambridge; On-site; CAD 75,000 - 110,000; Full time

Job summary

Septodont is seeking a Quality Engineer to investigate deviations in a pharmaceutical setting. You will follow established procedures to identify root causes and drive corrective and preventive actions.

You will coordinate across QA, RA, Validation, and Production teams, prepare investigation reports, and support on-floor problem solving. The role requires a university degree in a related science and at least 3 years of industry experience, with strong writing skills and knowledge of GMP.

Qualifications

• University degree in a related science required.
• Minimum 3 years’ experience in pharmaceutical QA/QC or Quality Engineering.
• Proficiency in root-cause analysis, CAPA tools and project management.
• Excellent technical writing skills and ability to document investigations clearly.
• Experience facilitating cross-functional teams and strong organizational skills.
• Fluent English communication (verbal and written).
• Knowledge of GMP principles and regulatory expectations.
• Proficiency with Word, Excel, and ERP systems.

Responsibilities

• Conduct investigations for deviations following established procedures.
• Identify critical path for investigations to timely determine root cause and CAPA.
• Ensure investigations are issued, tasks assigned, and closed timely.
• Coordinate deviations with SME teams to identify issues and root cause.
• Provide on-floor support for problem solving and root-cause identification.
• Initiate investigations for Operations per procedures.
• Identify root causes and corrective/preventative actions; review investigation reports.

Skills

Project management

Root Cause Analysis

CAPA Tools

Technical writing

Cross functional teams

Time management

English proficiency

Problem solving

GMP knowledge

MS Word / Excel / ERP

Education

University degree in a related science

Tools

ERP systems

Microsoft Word

Microsoft 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 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-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:

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.