Investigator, Deviations - Compounding

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.

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.

Duties and responsibilities

- 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.

Qualifications

- 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 asset.

- Ability to work effectively in a fast-paced, highly regulated environment while managing multiple priorities and meeting established timelines.

- Proven organizational and time management skills, with the ability to prioritize workload in collaboration with Compounding Management and cross-functional teams.

- Working knowledge of quality management systems and software applications, including TrackWise and Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

- Ability to identify compliance risks, analyze quality trends, and contribute to continuous improvement initiatives.

- Strong attention to detail and commitment to maintaining the highest standards of quality, compliance, and data integrity.

Background and Experience

- B.Sc. degree in a Chemistry stream or related discipline.

- Minimum of three (3) years of experience conducting investigations and writing Deviation Reports, Complaints, CAPAs, and Change Control in a pharmaceutical industry or equivalent experience.

- Minimum three (3) years of experience in the pharmaceutical industry in Operations, Quality Assurance or Quality Control department or equivalent experience.

- Strong understanding of the Pharmaceutical Industry.

Problem Solving:

- Any deviations to procedures, specifications or systems are brought to the Customer (Production manager), and Supervisor’s attention with logic, data and possible corrective measures

- Problems associated with a wide variety of quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc

- Problems associated with dealing with individuals from departments, and working on various functions within and outside Sun Pharma

Working conditions

- General conditions include office and warehouse work; mix of standing, walking, and desk work

- Clean environment

- Overtime as required or may need to periodically adjust working hours to meet with shift employees

Physical requirements

It will require extended periods of sitting and working with a personal computer with repetitive keyboard and “mouse” utilization cause potential eye-strain and sore muscles. Occasional lifting is required. Incumbent is responsible to obtain assistance with any lifting that they are not comfortable completing on their own.

Direct reports

N/A

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.