POSITION DESCRIPTION

Role / Position Title - Senior Quality Assurance Associate

Department/Function - Quality Assurance

Country - Canada

Region / City (within Country) - Toronto

FLSA (Exempt/Non-Exempt) - Exempt

POSITION SUMMARY

This position is responsible for ensuring quality systems work properly and in compliance with Good Manufacturing Practices and Health Canada Guidelines. This position is responsible for monitoring GMP-related activities for the company such as Product Releases, Deviation Management, Change Control Management, CAPA Management, Master document Management, SOP Management, Annual Confirmatory Testing program, and 3pl warehouse activities, etc.

OVERALL JOB RESPONSIBILITIES

Note: These statements are not intended to be an exhaustive list of all responsibilities and duties.

• Review government, regulatory and corporate policies to ensure all procedures are current and meet requirements.
• Review batch documents and other associated documents / QMS Events prior to batch release for distribution in line with Health Canada requirements.
• Maintain incoming inspection & release documents & supplier master documents.
• Co-ordinate warehouse QA activities for incoming inspection and release based on determined priorities. Manage 3pl- warehouse-related activities.
• Manage Method Transfer activities & assist supervisor with New Product Launches.
• Manage third-party lab testing for applicable products and manage the annual confirmatory testing program.
• Review stability reports, validation reports, and associated documents required to comply with Canadian GMP.
• Initiation, Investigation, review, closeout, and management of all Internal & external Nonconformance Deviations report pertaining to Canada Market products.
• Ensure initiation, review, closeout, and management of all internal & external change control records pertains to Canada Market products.
• Ensure the timely implementation of Identified CAPAs.
• Provides support for complaint investigations by logging complaints, gathering relevant information, following on corrective actions for timely approval, and closure of complaints.
• Communicate with sites to receive APQRs and Stability Reports as per the schedule. Identify risks and work with sites on the corrective actions, if required.
• Evaluate returned products, associated documentation, and provide product disposition.
• Participate in audits, audit response, and closing of resulting CAPAs
• Preparation, Review, and Management of SOPs &Management of Training.
• Perform other duties as assigned by the supervisor.

KNOWLEDGE, SKILLS AND ABILITIES

Education

• Minimum University level degree (B.Sc.) in a Science or Pharmacy discipline applicable to Health Canada Standards

Experience

• Minimum 5+ years of experience in the pharmaceutical industry, specifically in Quality Assurance/ Quality Control department working under Health Canada GMP regulations

Knowledge and Skills (Functional / Technical)

• Excellent communication skills, both written and verbal
• Knowledge of Health Canada Guidelines will be preferred
• Knowledge of GMP and regulatory requirements for the pharmaceutical industry.
• Strong proficiency with applicable computer software and MS applications

Physical demands and abilities

• The incumbent typically works in an office environment and uses a computer, telephone and other office equipment as needed to perform duties.
• The noise level in the work environment is typical of that of an office
• Incumbent may encounter frequent interruptions throughout the work day.
• The employee is regularly required to sit, talk, or hear; frequently required to use repetitive hand motion, handle or feel, and to stand, walk, reach, bend or lift up to 20 pounds

ABOUT GLENMARK

Glenmark is a global leader in the development and commercialization of generic drugs of the highest quality and value. We help to improve peoples’ lives every day by helping to reduce their healthcare costs while delivering high-quality medicines.

Established in 2003 as a North American subsidiary of Glenmark Pharmaceuticals, we launched our first generic product in January 2005 and quickly emerged as one of the leading generic organizations in the United States.

Today we have a diverse business. As a global leader in generics, we are leveraging our industry expertise and success to fuel extensive research to expand development in specialty branded products innovative products that are intended to have a major impact on how people live.

BENEFIT HIGHLIGHTS

• Paid time off
• 401k plus company match
• Company paid health benefits
• Dental
• Vision
• Onsite access to company gym
• Corporate Discount Program
• Paid Employee Referral Program
• EAP – Employee Assistance Program
• Accident Insurance
• Critical Illness Insurance
• Commuter Accounts
• Short-Term Disability
• Life and AD & D Insurance
• Whole Life Insurance
• Pet Insurance and so much more!

This job description is to serve as a guide. It is intended to be flexible and will continue to evolve over time with business needs and demands and may be updated periodically and at the Company’s discretion. Nothing in this position description changes or is intended to change the employment at-will relationship with the Company. Employment at-will means that an employee or the Company may terminate the employment relationship at any time, for any reason or no reason at all, with or without notice.

Glenmark Pharmaceuticals Inc USA is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.