Manufacturing Compliance Specialist

Septodont Group; Cambridge; On-site; CAD 70,000 - 110,000; Full time

Job summary

Novocol Pharmaceutical of Canada Inc. in Cambridge, Canada, is seeking a Manufacturing Compliance Specialist to lead investigations of deviations and root-cause analyses.

The role coordinates with QA, RA, Validation, and Production to implement corrective actions and ensure timely closure of actions. Responsibilities include writing investigation reports, conducting impact analyses, and maintaining open-investigation lists.

Qualifications

• University degree in a related science.
• Minimum of 3 years' experience in the pharmaceutical industry, Quality Engineering or QA/QC.
• Fluency in project management & RCA and CAPA 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.

Responsibilities

• Conduct investigations for deviations following existing procedures.
• Identify root cause and corrective & preventative actions.
• Ensure investigations are issued; tasks assigned and closed timely.
• Coordinate with SME and relevant teams to identify issues and root cause.
• Write and review investigation reports for completeness before approval.
• Conduct impact analysis of proposed corrective & preventative actions.
• Prepare and maintain lists of open investigations for Cambridge Management.
• Review progress with Production Management to ensure alignment.
• Facilitate weekly deviation huddle and support KPIs.
• Project manage CAPAs and follow-up.

Skills

Project management

Root Cause Analysis

Corrective Action Tools

Technical writing

Cross-functional teamwork

Organizational skills

Time management

Independent work

English proficiency

Critical thinking

GMP knowledge

ERP proficiency

Education

University degree in a related science

Tools

ERP systems

MS Office

Job description

## Manufacturing Compliance SpecialistPostuler: Cambridge (Canada): À temps plein: Offre publiée aujourd'hui: JR10588**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 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.