Specialist Quality Assurance (Technical Quality)

Sun Pharmaceutical Industries Ltd•Brampton, ON

8d•CA$63,000 - CA$78,500•Onsite

About The Position

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, 21CFR 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.

Requirements

Exceptional verbal and written communication skills, including technical report writing ability combined with project management foundations.
Computer literacy combined with broad technical knowledge and ability to understand and analyze technical systems (mechanical, electrical & scientific) is required in order to provide value-added input into the Protocol development and execution process.
Knowledge of the principles and application of current Good Manufacturing Practices (cGMP) specifically related to Commissioning & Qualification (C&Q) of facilities, utilities and equipment and Process/Cleaning Validation activities.
Ability to work both independently and in a team to achieve objectives.
Innovative quality-oriented mindset combined with strong problem-solving ability.
Comfortable multi-tasking, investigating and managing problems that can be more than routine in nature.
Extensive cross-functional collaboration with technical/scientific professionals, plant staff, admin staff, international counterparts (e.g. global quality).
University degree in Science and /or Engineering
5 years’ experience in a Pharmaceutical industry environment.
Detailed Knowledge of regulatory requirements for the pharmaceutical industry, including broad knowledge of Good Engineering Practices (GEP), Validation Lifecycle and Quality by Design (QbD).
Strong Knowledge of Change Control Systems.
Working knowledge of 21 CFR Part 11, GAMP and GxP electronic systems and Data Integrity.
Familiar with industry applications such as Trackwise, SAP, Manufacturing Execution Systems and Validation tools
Software skills (Microsoft Word, Excel, PowerPoint, Teams, Document management).

Responsibilities

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; Qualification / Validation Plans & Study Protocols; 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 PharmaTech, 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 PharmaTech 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 organization.