Investigator, Deviations - Compounding

Driven by abold pursuit of science and fueled byan unwavering commitment to patients, Sun Pharma is a leading global pharmaceutical company, providing high-quality medicines trusted by healthcare professionals and patients.

As part of our mission to Reach People and Touch Lives, we deliver

Innovative Medicines, Generics and Consumer Healthcare products that improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, weimprove access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives.

The primary responsibility of this role is to provide compliance and investigation support to ensure adherence to Sun Pharma quality standards, cGMP requirements, and applicable regulatory expectations. The position is responsible for coordinating, leading, and supporting investigations, customer complaints, deviations, and CAPA activities, ensuring they are conducted thoroughly, accurately, and completed within established timelines. The role works closely with cross-functional teams to identify root causes, implement effective corrective and preventive actions, and drive continuous improvement while maintaining a high level of compliance and product quality.

• Ensure all activities related to the detection, investigation, and resolution of nonconformities are completed in a timely manner and in compliance with company policies, GMP requirements, and regulatory standards.
• Lead all activities associated with unplanned deviations and investigations, including the preparation of investigation reports and related documentation.
• Maintain a strong presence on the production floor to develop a thorough understanding of compounding systems, processes, and applications, and conduct interviews with personnel involved in quality incidents.
• Collaborate with Subject Matter Experts (SMEs) and cross-functional teams to identify and establish the root causes of quality incidents.
• Conduct comprehensive root cause analyses using established methodologies such as 5 Whys, Fishbone (Ishikawa) Analysis, Failure Mode and Effects Analysis (FMEA), and other problem-solving tools.
• Develop and recommend effective corrective and preventive actions (CAPAs) based on investigation findings and root cause analysis outcomes.
• Partner with Compounding Management, Quality Assurance Investigation teams, and other stakeholders to ensure timely closure of investigations.
• Provide support for CAPA implementation, closure, and effectiveness verification activities.
• Participate in investigations related to customer complaints and contribute to root cause determination and CAPA development.
• Support Quality Assurance in identifying trends, recurring deviations, and systemic quality issues, and recommend continual improvement initiatives.
• Develop and deliver training materials related to CAPAs, deviations, investigations, and quality systems as required.
• Assist Compounding Management with Change Control activities and Standard Operating Procedure (SOP) revisions.
• Participate actively in internal audits and support audit readiness initiatives.
• Contribute to continuous improvement programs by identifying opportunities to enhance quality, compliance, and operational efficiency.
• Perform additional quality and compliance-related responsibilities as assigned.

• Thorough knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), FDA regulations, Health Canada regulations, and applicable industry guidance documents.
• Knowledge of pharmaceutical manufacturing and compounding processes is considered an asset.
• Strong analytical, investigative, and problem-solving skills, with demonstrated ability to conduct effective Root Cause Analysis (RCA).
• Proficiency in root cause investigation tools and methodologies, including 5 Whys, Fishbone (Ishikawa) Analysis, and Failure Mode and Effects Analysis (FMEA).
• Excellent interpersonal skills with the ability to collaborate effectively across multiple departments and foster strong working relationships.
• Strong written and verbal communication skills, with the ability to communicate complex technical and compliance-related information clearly and effectively.
• Demonstrated technical writing skills, including preparation of investigation reports, CAPAs, deviation reports, and procedural documentation.
• Previous experience in the pharmaceutical industry is preferred and considered a strong…