Title:  Associate Quality Assurance (Quality Engineering)

Driven by a bold pursuit of science and fueled by an 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, we improve access to effective, affordable treatments that promote better health and well-being.

Reaching People. Touching Lives. 

Job purpose

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:

1. Equipment/Facilities/Utilities Qualification
2. Manufacturing Process & Cleaning Validation
3. Maintenance/Calibration programs

Duties and 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.
•       Other duties as assigned. 

Knowledge, Skills and Abilities:

• 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).

Additional responsibility (Only applicable to customer facing roles)

Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day

Qualifications

• 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).
  
  

Working conditions

• Generally, fairly pleasant surroundings and level temperatures. 
• Mixture of sitting, standing and walking
• Demands on time
• At times requires concentration for long periods.

Physical requirements

Office based role

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $70,000  to $87,500. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; RRSP savings plan; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time.

The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility. If hired, the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors.

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, ethnic origin, citizenship, ancestry, sex, age, marital status, family status, physical or mental disability, gender identity, gender expression or any other ground protected by applicable human rights legislation.

The Company uses artificial intelligence to screen, assess or select applicants.

Notice to Agency and Search Firm Representatives:   Sun Pharmaceuticals Industries, Inc. (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting.  Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun.  No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.