Associate, Quality Assurance (Investigations)

Sun Pharma; Brampton; Hybrid; CAD 69,000 - 86,000; Full time

Job summary

Sun Pharma in Canada is seeking an Associate, Quality Assurance (Investigations) to ensure products are manufactured, tested and released in compliance with GMP and company standards. The role focuses on investigations of deviations, OOS/OT and lab events, providing guidance to SMEs and performing risk assessments.

You will lead root-cause analysis, CAPAs, training, and participate in audits within a dynamic pharmaceutical environment.

Qualifications

• Bachelor's degree in Science or related discipline.
• Minimum 3 years' experience in Quality Assurance, Quality Control or Manufacturing in pharma.
• Good working knowledge of pharmaceutical Quality Systems.
• Experience coordinating team activities.
• Experience interacting with Health Canada and FDA.
• Knowledge of HC and FDA regulations.

Responsibilities

• Support investigations related to manufacturing/packaging and Quality Control functions.
• Identify root cause and perform risk assessments.
• Ensure non-conformances are resolved per regulatory requirements and timelines.
• Maintain Lead Investigator and Approver certifications.
• Engage SMEs from QC and Production in investigations and discussions.
• Manage TrackWise access and site training; act as TrackWise Superuser.
• Assess CAPA effectiveness and ensure timely action follow-up.
• Identify regulatory requirements for investigations and implement at the site.
• Deliver training on Root Cause Analysis, Investigations and CAPAs.
• Collaborate with other departments to build quality into processes and systems.
• Assist with Change Controls and SOPs as required.
• Participate in Internal, Customer and Regulatory Audits.

Skills

Root-cause analysis

Communication

Team coordination

Quality systems knowledge

Education

Bachelor's Degree in Science

Tools

TrackWise

LMS

EDMS

SAP

Job description

Driven by abold pursuit of scienceand 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 toReach People and Touch Lives, we deliverInnovative Medicines, Generics and Consumer Healthcare productsthat improve the lives of millions of people. With a broadly diversified portfolio of products that span multiple therapeutic areas, weimprove access to effective, affordable treatmentsthat promote better health and well-being.

Reaching People. Touching Lives.

Job purpose

Associate, Quality Assurance (Investigations) is responsible for ensuring products are manufactured, inspected, tested and packaged according to GMP and Company requirements. This is done on a day-by-day basis by the ensuring deviations and non-conformance investigations are managed in compliance with Sun Pharma Global Quality Standards, GSOPs, SOPs and Regulatory requirements.

In addition, Associate, Quality (Investigations) is accountable to ensure effective guidance for the QC Subject Matter Experts on Out-Of-Specification, Out-Of-Trend and Lab Event records and identification of the root cause, assessment of the associated risks and establishment of the effective CAPAs.

Duties and responsibilities

• Support investigations associated with manufacturing/packaging, and/or Quality Control functionality such as Out- Of -Specification, Out-Of-Trend, Lab Events and Deviations
• Ensure identification of the root cause of the issue and execute risk assessments based on the findings of the investigation
• Ensures that all activities related to the recognition, investigation and resolution of non-conformities are performed in a timely manner and in compliance with the company and regulatory requirements
• Obtain and keep current Lead Investigator and Approver certification status as per the Certification Program requirements
• Ensure appointment of the Subject Matter Experts (SMEs) from the QC and Production and their participation in the investigation’s execution and Board discussions
• Support all activities associated with Investigator and Approver Certification Program
• Manage TrackWise access and system training of the site personnel involved in the investigations based on their training and certification status, perform the role of the TrackWise Superuser at the site
• Ensure assessment of the CAPAs effectiveness and timely execution of all the associated actions
• Identify relevant regulatory requirements for non-conformance investigations and ensure their implementation in the facility
• Deliver training related to Root Cause Analysis, Investigations and CAPAs to the site personnel
• Work with other departments to proactively build quality into the processes and systems
• Develops or assists with Change Controls and SOP's as required
• Participate in Internal, Customer and Regulatory Audits
• Other duties as assigned

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

• Bachelor's Degree in Science, or related discipline
• Minimum 3 Years' experience in a Quality Assurance, Quality Control or Manufacturing experience role within the pharmaceutical industry preferably in handling non-conformance investigations.
• Good working knowledge of pharmaceutical Quality Systems.
• Experience in coordinating team activities
• Experience in dealing directly with Regulatory Agency officials (Health Canada and FDA,)
• Sound knowledge and application of Health Canada and FDA regulations
• Knowledge of pharmaceutical standards, transfer guidelines, validation requirements
• Capable of leading by influence in matrix environment
• Strong focus on flexibility, ability to multi-task, attention to detail, excellent organizational skills, good follow-up, excellent communication and writing skills
• Experience in Quality electronic systems such as Trackwise, Learning Management System (LMS), Electronic Documentation Management System (EDMS), and SAP is an asset

Working conditions

• Non-routine and complex problems
• Dealing interdepartmentally/across sites to attempt to obtain facts in a rapidly changing atmosphere
• Ability to work under stressful conditions and prioritize workload
• Numerous and varied responsibilities demanding attention and detail

Physical requirements

• Office based role

This posting is for an existing vacancy.

The presently-anticipated base compensation pay range for this position is $68,500 to $85,500. 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.