Specialist Quality Assurance; Technical Quality

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Date:
Jul 24, 2026

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.

To provide Technical Quality oversight (Validation, Engineering Controls, Maintenance and Calibration) for Sun Canada’s manufacturing facilities, utilities, equipment, laboratories and processes.

This role collaborates cross-functionally with system owners and their supporting technical teams (e.g. process development, engineering, validation, maintenance, metrology) to provide regulatory guidance and implement procedures and standards that ensure sustained compliance with Sun policies and GMPs (US FDA, 21

CFR part 11, Health Canada, GAMP).

This includes evaluation and approval of validation, engineering and change control documentation pertaining to the following technical operations areas:

• Equipment/Facilities/Utilities Qualification
• Manufacturing Process & Cleaning Validation
• Maintenance/Calibration programs

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• Provide QA oversight for processes, procedures and validation activities for equipment, facilities, utilities, process, packaging and cleaning validations. Ensure compliance to US FDA, 21 CFR part 11, Health Canada, GAMP and Sun requirements, and apply the principles of “Qualification by Design”.
• Interface with the QA-IT group to align on requirements for Computerized Systems Validation if required.
• Collaborate with other subject matter experts for development of validation deliverables, including:
• High Level and Functional Risk Assessments;
• User/Functional Requirements Specifications;
• Traceability Matrices
• Deviation Reports
• Validation Summary Reports.
• Oversee and approve robust validation project plans that employ a scientific risk-based approach for identification of the critical quality attributes based on critical process parameters.
• Participate and lead meetings with Pharma Tech, Validation, Production, Engineering, Metrology, Maintenance, QA IT, and other users/ owners/ stakeholders in order to gain cross functional understanding and obtain consensus on risk, protocol content and validation approach.
• Provide technical quality support and expertise to the Validation and Pharma Tech teams and to the operators in the manufacturing area on equipment, process and cleaning validations as needed.
• Provide technical quality support and expertise to the Engineering, Maintenance and Metrology teams, as needed, to implement effective risk-based equipment, facility and utilities Maintenance programs.
• Maintain up to date knowledge of evolving regulatory requirements/trends, and availability of current/new techniques for equipment, process, cleaning, calibration, maintenance and computerized systems validation;
  Review / perform gap analysis and provide feedback on corporate guidelines and regulations.
• Review proposed changes to validated systems and identify the validation/change control requirements necessary to maintain the system’s validation status after execution of the change.
• As required, act as a designate approver for the Senior Manager, Technical Quality & Engineering with respect to engineering/ validation/ calibration/ maintenance related documentation, including protocols, risk assessments, specifications, work orders and change controls.
• Participate in and/or lead Audits and Non-Conformance Investigations, as required. Support system owners in the development and execution of CAPA plans, and review/approve outcomes to ensure timely implementation and effectiveness.
• Duties may require frequent cross-functional contact within the…