Quality Assurance Associate

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.

Roles & Responsibilities

• 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 CoAs CoMs 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: Bachelors Degree in scientific discipline (chemistry pharmaceutics biology or another related science)

Minimum work experience: Five years 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
• Strong communication (verbal written)
• 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. Reddys why they come to work every day and theyll say because Good Health Cant 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 were 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. 

For more details please visit our career website at Work :

No

Employment Type :

Full-time