Lead Associate, Quality

4 days ago


Mississauga, Canada Dr. Reddy's Laboratories, Inc. Full time

**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 seek dynamic and energetic individuals ready to inspire and make a difference for _their_ community and _every_ community.

**Diversity, Equity & Inclusion**
***

We are looking for Lead Associate, Quality to provide end to end support and coordination within the Quality function and system owners to ensure compliant and timely release of our products in the Canada market and operate per Health Canada regulations. The role will be based in our Mississauga, Canada office and will report to Quality Head - Canada

**Job Duties & Responsibilities**:

- Ensures adherence to quality, health and safety, Good Manufacturing Practice and good distribution practice and management of Quality Systems to maintain quality standards.
- Develops knowledge of quality processes within own team; resolves routine issues that arise within the quality team to maintain compliance standards; escalates complex issues to senior management.
- Provides support to other Quality Systems owners with quality initiatives in order to ensure compliance with required standards and continued quality improvements.
- Provides quality support internally and coordinates interdepartmental activities with Regulatory Affairs, Supply Chain and Operations.
- Processes complaints in the Medical Information Management System (Miracle).
- Provides support for deviation, change control management, Annual Product Quality Reviews (APQRs) and the review of stability data.
- Manage batch release activities by reviewing batch release documentation: manufacturing batch records, CoA’s, CoM’s, etc. to ensure Canadian GMPs are met.
- Manages the sample request/destruction program.
- Evaluates associated temperature data, product returns and other activities/projects as assigned.
- Initiates deviations, investigations and change controls when required.
- Functions as the batch release and documentation SME 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.
- Ensure the Annual Product reviews are performed on time.
- Responsible for other assigned duties.

***

**Qualification**:

- Bachelor’s Degree in scientific discipline (chemistry, pharmaceutics, biology or another related science).
- Minimum three to eight years of experience in a Quality Assurance role in the pharmaceutical or biotechnology industry is preferred.
- 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)

Must be local to Canada, a lawful permanent resident/citizen of Canada. or otherwise authorized to work in Canada without requiring sponsorship now or in the future.

**COVID-19 Vaccination**
***
Vaccination remains the most effective way to halt the spread of the COVID-19 pandemic, and Dr. Reddy’s encourages all employees to be vaccinated. At this time, vaccinations are not mandated for Princeton-based employees but may become required in the future. Weekly COVID testing is mandatory for all employees who have not uploaded proof of vaccination or who are not fully vaccinated.
- Equal Opportunity Employer:_
- An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability._



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