Deviation Investigation Lead, Quality & Compliance

Sun Pharmaceutical Industries, Inc.; Canada; Remote; CAD 99,000 - 124,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision coverage

Life insurance

RRSP benefits

Employee assistance program

Job summary

Sun Pharmaceutical Industries, Inc. is seeking a Quality Compliance Investigator to support investigations, deviations, CAPAs and change controls in a highly regulated environment.

You'll partner with cross-functional teams on root-cause analyses using structured methods and ensure timely closure of CAPAs, aiming to sustain product quality and regulatory compliance across manufacturing operations in Canada.

Qualifications

• Thorough knowledge of cGMP, GDP, FDA and Health Canada regulations.
• Experience with RCA tools: 5 Whys, Ishikawa, FMEA.
• Experience in pharmaceutical manufacturing/compounding is an asset.
• Strong written and verbal communication, technical writing of reports.
• Ability to work in a fast-paced regulated environment and manage multiple priorities.

Responsibilities

• Detect, investigate, and resolve nonconformities per GMP and policies.
• Lead investigations and prepare investigation reports.
• Maintain presence on production floor to understand compounding processes.
• Collaborate with SMEs to identify root causes.
• Develop and implement CAPAs and verify effectiveness.
• Support change control and SOP revisions.
• Participate in internal audits and audit readiness.
• Identify trends and drive continuous improvement.
• Deliver training on CAPAs, deviations, investigations, and quality systems.

Skills

cGMP knowledge

Root Cause Analysis

Investigation skills

Analytical skills

Excellent communication

Education

BSc Chemistry

Tools

TrackWise

Microsoft Office

Quality Systems

Job description

Sun Pharmaceutical Industries, Inc. is seeking a Quality Compliance Investigator to support investigations, deviations, CAPAs and change controls in a highly regulated environment.

You'll partner with cross-functional teams on root-cause analyses using structured methods and ensure timely closure of CAPAs, aiming to sustain product quality and regulatory compliance across manufacturing operations in Canada.