Quality Assurance Associate

Dr. Reddy's Laboratories; Mississauga; On-site; CAD 60,000 - 80,000; Full time

Job summary

Dr. Reddy's Laboratories seeks an Associate in Quality Assurance to ensure GMP compliance and quality standards in drug importation. The ideal candidate will possess a Bachelor's Degree in a scientific discipline and have substantial experience in Quality Assurance within the pharmaceutical sector. Join us in making significant healthcare breakthroughs.

Qualifications

• Five years of experience in a Quality Assurance role in the pharmaceutical or biotechnology industry preferred.
• Experience with GMP regulations and product quality compliance required.

Responsibilities

• Supports GMP compliance and quality activities for product importation.
• Manages deviation and CAPA processes in the QMS.
• Conducts batch release activities to ensure compliance with Canadian regulations.

Skills

Analytical thinking

Attention to detail

Teamwork

Education

Bachelor’s Degree in scientific discipline (chemistry, pharmaceutics, biology)

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Job description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference fortheircommunity andeverycommunity.

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background.

Job Description

We are seeking an Associate, Quality Assurance to be based out of our Canada office. This position provides support to the DRL, Canada quality function by working with quality systems, and within established procedures in order to facilitate GMP compliance and regulations for drug products. The role is responsible for quality activities in relation to product importation and identifies/reports quality/compliance issues and ensures adherence to quality, Good Manufacturing Practice and good distribution practice.

This role reports to Head of Quality - Canada and works closely with multiple functions including, but not limited to Sales, Marketing, Supply Chain, Regulatory Affairs, Third Party Partners/Vendors, Customers and Health Canada.

• Ensures adherence to Pharmaceutical quality, health and safety, Good Manufacturing Practice and good distribution practice and management of Quality Systems to maintain quality standards
• Carries knowledge of quality processes, resolves routine issues that arise within the Quality Team to maintain compliance standards; escalates issues to manager for resolution
• Understands and implements GMP regulations in relation to product release, especially activities around imported products, and handling 3PL vendors
• Provides QA/QC support internally and coordinates interdepartmental activities with Regulatory Affairs, Supply Chain and Operations
• Processes complaints in the Medical Information Management system and lead them to closure
• Responsible for initiation, management and completion of QMS – Deviation, CAPA, Change Controls to ensure adequate documentation
• Prepares and reviews Annual Product Quality Review (APQRs) and stability reports to ensure compliance to marketed products
• Performs batch release activities by reviewing batch release documentation such as: manufacturing batch records, CoA’s, CoM’s, and all allied activities as per SOPs to ensure that Canadian GMPs are met
• Manages the sample requests, returns, product hold and destructions process
• Evaluates temperature data for incoming finished products and make informed decision about impact to products
• Functions as the documentation specialist managing the Quality Assurance SOPs, including: biennial reviews, revisions, generation, etc. and oversees administrative activities for the Quality department including: filing, maintaining master documents, etc.
• Ensures training is completed for new employees and training records are current.
• Responsible to address issues and identify trends that help to ensure compliance, development and implementation of process improvements.

Qualifications

Educational qualification: Bachelor’s Degree in scientific discipline (chemistry, pharmaceutics, biology or another related science)

Minimum work experience: Fiveyears of experience in a Quality Assurance role in the pharmaceutical or biotechnology industry is preferred

Skills & attributes:

• Demonstrated ability to work in a team environment within the quality department to ensure all aspects of GMP are met from a product quality and compliance standpoint
• Experience in reading and understanding analytical test results on certificates of analysis along with knowledge of Good Manufacturing Practices (GMPs) in pharmaceutical production processes (i.e. injectable products, solid dosage forms, semi-solids, and liquids)
• Strong planning and organization computer literacy (Word, Excel, PowerPoint)
• Strong analytical thinking required
• Superior attention to accuracy and details
• Ability to work independently and in cross-functional team settings
  

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Additional Information

Our Work Culture

Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.

Equal Opportunity Employer

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.