Associate, Quality Assurance

3 days ago

Brampton, Canada Sun Pharma Canada Inc. Full time

**Title**:Associate, Quality Assurance**:

- Date: May 2, 2025
- Location: Sun Pharma Canada Inc.
- Company: Sun Pharma Canada Inc.

Job purpose

The Associate, Quality (Investigations and QA of QC) will be responsible for supporting Quality Assurance activities related to laboratory operation to ensure compliance with cGMP, GLP, regulatory requirements and Sun Pharma internal procedures and processes.

In addition, Associate, Quality (Investigations and QA of QC) is to provide guidance to QC Subject Matter Experts on Out-Of-Specification, Out-Of-Trend and Lab Event records and identification of the root cause, assessment of the associated risks and establishment of the effective CAPAs.

Duties and responsibilities
- Review and Approval of investigations associated with Quality Control functionality such as Out
- Of -Specification, Out-Of-Trend and Lab Events to support timely batch release
- Review and Approval of Laboratory GMP documents such as Raw Material, Stability and Finished Good Specifications, Analytical Test Methods, Test Method Validation and Verification and associated reports etc.
- Review of the Compendial method updates
- Ensure identification of the root cause of the issue and execute risk assessments based on the findings of the investigation
- Ensures that all activities related to the recognition, investigation and resolution of investigations are performed in a timely manner and in compliance with the company and regulatory requirements
- Lead Investigator for the Manufacturing Investigations due to OOS in TrackWise
- Assign action items to SME’s ensuring actions are progressing quickly including creation of CAPA
- Obtain and keep current Lead Investigator and Approver certification status as per the Certification Program requirements
- Develop and present critical finding or progress of an investigation to QA Leadership
- Manage extension request and CAPA Effectiveness check in TrackWise
- Identify recurring quality investigations and ensure appropriate actions are taken such as Management notification
- Support the Recall activities
- Other duties as assigned

**Qualifications**:

- Bachelor's Degree in Science, or related discipline
- Experience with OOS investigations
- Minimum 3 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical industry preferably in handling OOS and non-conformance investigations.
- Good working knowledge of pharmaceutical Quality Systems (ie: Deviations, CAPA, change controls, etc)
- Experience in review and approval of Method Validation protocol and reports
- Capable of leading by influence in matrix environment
- Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
- Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS), Electronic Documentation Management System (EDMS), and SAP is an asset

Working conditions
- Non-routine and complex problems
- Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
- Ability to work under stressful conditions and prioritize workload
- Numerous and varied responsibilities demanding attention and detail

Physical requirements
- Hybrid based role (3 days in the office)
- Regular hours are 8:00am to 4:30pm or 9:00am to 5:00pm, with extended hours as required to resolve urgent issues

Direct reports

N/A

  • Quality Assurance Specialist

    2 weeks ago

    Brampton, Canada Sarangi Quality Corp. Full time

    Sarangi Quality Corp., located in the heart of Brampton, is a leading provider of quality assurance and inspection services. We are dedicated to helping our clients maintain the highest standards in product quality, reliability, and compliance. With a focus on precision and attention to detail, our team works across diverse industries to ensure products meet...

  • Quality Assurance Associate

    2 weeks ago

    Brampton, Canada Jones Healthcare Group Full time

    Join Jones Healthcare Group - Where Innovation Meets Purpose! At Jones, we’re committed to the environment, our team, communities, and consumers, and we're inspired to make a meaningful impact through advanced packaging and medication dispensing solutions. **Summary of position**: **If you love** ensuring every detail aligns with quality standards, then...

  • Field Operations and Quality Assurance Associate

    1 week ago

    Brampton, Canada Arelli Commercial Cleaning Full time

    Arelli Cleaning Inc. is a thriving commercial cleaning company that provides exceptional cleaning & disinfection services to businesses in the GTA area. As we embark on the next stage in our journey — expanding to new cities & areas, we are looking for a Part-time **Field Operations and Quality Assurance Associate** to join our journey to success. **_What...

  • Quality Assurance Technician

    1 week ago

    Brampton, Canada Give and Go Foods Full time

    Give & Go Prepared Foods Corp.is a proud member of the Mondelēz family. We are a leading, and growing, North American manufacturer of baked goods for over 30 years. If you're looking for a company that will provide you with opportunities for career growth and development, while working with an energetic and team with deeply ingrained values of respect,...

  • Quality Assurance Technician

    1 week ago

    Brampton, Canada Give and Go Prepared Foods Full time

    **Available Shift**: - Day Shift - 12 hour shift - Night Shift - 12 hour shift **Positions Available**: Humber Facility - 300 Humber College Blvd, Etobicoke, ON IM2 Facility - 725 Intermodal Dr, Brampton, ON **Key Responsibilities**: - Provide technical leadership in the areas of food safety and quality systems - Ability to provide leadership to the to...

  • Quality Assurance Auditor

    2 weeks ago

    Brampton, Canada Aurora Cannabis Full time

    **Quality Assurance Auditor** **Employment Type**: Permanent Full-time **Job Location**: Brampton **Hours**: 40 hours per week **A LITTLE ABOUT US** We are a global cannabis company driven by our passion to help people improve their lives. We have a diverse team who bring their best every day so Aurora can be the cannabis provider of choice for patients...

  • Quality Assurance

    6 days ago

    Brampton, Canada Saint Gobain Full time

    **WHY DO WE NEED YOU?** We are currently looking for a Quality Control Supervisor at our Brampton plant. The incumbent is responsible for leading the quality systems and process control strategy related to production at the Brampton, ON plant. The incumbent will lead efforts to analyze and reduce variations in processes, develop preventive measures and...

  • Quality Assurance Specialist

    6 days ago

    Brampton, Canada Regional Municipality of Peel Full time

    **Job Description**: **Quality Assurance Specialist - Technology (Salesforce)** **IT Solutions Division** **Contract Full-Time; 13 Months* **_david will reconfirm duration with Peter_ **Pay Band: $84,335 - $105,417 per annum** **Overview**: The Digital Services Team (“DST”) is actively working towards improving the technology experience and advancing...

  • Quality Assurance Specialist- Technology

    1 week ago

    Brampton, Canada Regional Municipality of Peel Full time

    **Job Description**: **Quality Assurance Specialist - Technology (Salesforce)** **Corporate Services - IT Solutions** **Status**:(2) Contract Full Time - Up to 18 months **Salary Range**:$89,469-$111,834 per annum **Work mode**:Hybrid* _see below for more details about this work mode._ **Location**:10 Peel Centre Drive, Brampton **Hours of work**: 35...

  • Coordinator, Quality Assurance

    3 days ago

    Brampton, Canada WILL Cannabis Full time

    **Coordinator, Quality Assurance** - **Work Location**: On-site, Brampton (90%) and Dunnville (10%) - **Travel Requirements**: 10% or less, within Ontario - **Hours of Work**: 9:00 AM to 5:00 PM **Duties and Responsibilities**: - Support the Quality Assurance Person in ensuring operations are performed in accordance with Cannabis Regulations, GPP, and...