Associate Quality Assurance

3 weeks ago

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

**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.

**D**
**iversity, Equity & Inclusion**

We are looking for an **Associate Quality Assurance** for our Canadian Headquarters in Mississauga, ON. The incumbent will 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 report to Quality Head - Canada

**Responsibilities**:

- Possess 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 to ensure compliance with required standards and continued quality improvements
- Carries strong understanding of Canadian quality release process for the imported products from overseas
- Strong understanding of reviewing RM and FP specification, test methods and able derive conclusive outcome to perform product release
- Holds direct or indirect experience with pharmaceutical manufacturing process and review of manufacturing and packaging batch records including sterile and non-sterile products
- Manage batch release activities by reviewing batch release documentation: manufacturing batch records, CoA’s, CoM’s, etc. to ensure Canadian GMPs are met
- Responsible for sample management including creating sample request form, reconciliation, coordination with Canadian warehouse and completing sample tracking log
- Evaluates temperature excursion data, product returns and other activities/projects as assigned - Manage logs and provide product disposition by reviewing product impact assessments
- Knowledge of deviations, CAPA, change control and following through their timely closure
- Provides support for Annual Product Quality Reviews (APQRs), data trending and the review of stability data
- Ensures training is completed for new employees and training records are current; manage training program for the company employees
- Responsible to address issues and identify trends that help to detect compliance issues, development and implementation of process improvements
- Responsible for other duties as assigned

**Education & Experience**:

- Bachelor’s Degree in scientific discipline (chemistry, pharmaceutics, biology or another related science)
- Minimum two to five 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 skills
- Proficiency in Microsoft Office (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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