Associate, Quality Assurance

Sun Pharmaceutical Industries, Inc.; Brampton; Hybrid; CAD 60,000 - 90,000; Full time

Job summary

An established industry player is seeking an Associate in Quality Assurance to support laboratory operations and ensure compliance with regulatory standards. In this hybrid role, you will guide Quality Control experts on investigations and manage root cause analyses. The position involves reviewing critical documents, leading investigations, and collaborating across departments to resolve complex quality issues. If you have a strong background in QA within the pharmaceutical industry and are looking for a challenging yet rewarding opportunity, this role is perfect for you.

Qualifications

• 3+ years in QA, QC, or manufacturing roles in pharmaceuticals.
• Strong knowledge of pharmaceutical Quality Systems.
• Experience with OOS and non-conformance investigations.

Responsibilities

• Review and approve investigations for Quality Control functions.
• Lead investigations for manufacturing OOS issues.
• Develop and present investigation findings to QA leadership.

Skills

OOS Investigations

Quality Assurance

Risk Assessment

Regulatory Compliance

Communication Skills

Education

Bachelor's Degree in Science

Tools

TrackWise

LMS

EDMS

SAP

Job description

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

In addition, the 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, including identification of the root cause, assessment of the associated risks, and establishment of effective CAPAs.

Duties and Responsibilities

1. Review and approve investigations related to Quality Control functions such as Out-Of-Specification, Out-Of-Trend, and Lab Events to support timely batch release.
2. Review and approve laboratory GMP documents such as Raw Material, Stability, and Finished Good Specifications, Analytical Test Methods, and associated reports.
3. Review updates to compendial methods.
4. Identify root causes of issues and perform risk assessments based on investigation findings.
5. Ensure all activities related to recognition, investigation, and resolution of issues are performed timely and in compliance with company and regulatory requirements.
6. Lead investigations for manufacturing OOS issues using TrackWise.
7. Assign action items to SMEs, monitor progress, and create CAPAs.
8. Maintain current Lead Investigator and Approver certifications as per program requirements.
9. Develop and present investigation findings or progress updates to QA leadership.
10. Manage extension requests and CAPA effectiveness checks in TrackWise.
11. Identify recurring quality issues and ensure appropriate management actions, including notifications.
12. Support recall activities as needed.
13. Perform other duties as assigned.

Qualifications

1. Bachelor's Degree in Science or related discipline.
2. Experience with OOS investigations.
3. Minimum of 3 years' experience in QA, QC, or manufacturing roles within the pharmaceutical industry, especially handling OOS and non-conformance investigations.
4. Good knowledge of pharmaceutical Quality Systems (Deviations, CAPA, change controls, etc.).
5. Experience reviewing and approving Method Validation protocols and reports.
6. Understanding of Health Canada and FDA regulations.
7. Ability to lead influence in a matrix environment.
8. Strong organizational skills, attention to detail, and effective communication skills.
9. Experience with electronic quality systems such as TrackWise, LMS, EDMS, and SAP is an asset.

Working Conditions

• Handling non-routine and complex problems.
• Collaborating across departments and sites in a dynamic environment.
• Working under stressful conditions with multiple priorities.

Physical Requirements

• Hybrid role (3 days in-office).
• Standard hours are 8:00 am to 4:30 pm or 9:00 am to 5:00 pm, with extended hours as needed.