Associate, R&D QA Lab Review

Apotex
Posted

Post Expires

Type

Executive / senior industry position

Associate, R&D QA Lab Review

Company: Apotex

 

Apotex is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines (both generic and innovative pharmaceuticals) for patients around the world. We are the 7th largest generic pharmaceutical company globally with more than 12,000 employees and estimated sales of approximately $3 billion. Our fully integrated operation is comprised of four lines of business: Global Generics; Apobiologix; Global Active Pharmaceutical Ingredients (API); and ApoPharma (Innovative Products). With our worldwide manufacturing sites, Apotex can produce up to 24 billion dosages per year. We produce 300 medicines in 4,000 dosages and formats that are exported to 115 countries. Apotex will spend $2 billion over the next 10 years on research and development.

 

Job Summary

The Associate, R&D QA Lab review RD8 is responsible for monitoring the quality of all aspects of R&D Quality Control and Analytical Development laboratories in the GTA Solid Dose sites.  The associate provides disposition decisions for experimental raw materials, semi-finished goods and non-commercial finished products.  Other responsibilities include review and approval of method validation protocols, reports, laboratory investigation records and change control.  Furthermore, this role is expected to provide leadership and mentoring to junior associates.

Job Responsibilities

  1. Audit raw data to release of R&D drug actives (APIs), experimental excipients and non-commercial finished product batches.
  2. Audit analytical lab investigations and deviation reports for APIs, excipients and non-commercial finished product batches.
  3. Review, coordinate and approve activities for investigations and deviations for R&D materials and processes.
  4. Review and approve R&D specifications, laboratory protocols and reports for method validation and technology transfer of analytical procedures.

5.  Audit and approve additional R&D reports and documents supporting submission of a regulatory filing.

6.  Assist in the preparation activities leading up to Regulatory or customer inspections.

7.  Represent R&D QA during inter/intra departmental meetings as required.

8.  Assist in training and mentoring junior members of the team.

9.  Act as delegate for supervisor as required.

10.  Review and approve R&D change control requests.

11. Works as a member of a team to achieve all outcomes.

12. Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrate strong and visible support to our values

13. Performs all work in accordance with all established regulatory and compliance and safety requirements.

14. All other duties as assigned.

Job Requirements

  • Minimum of 5 years of experience in the pharmaceutical industry, 2 years in Quality Assurance
  • Knowledge of GMP and cGMPs requirements
  • Knowledge of analytical method validation requirements
  • Experience with chromatography techniques (HPLC, LC/MS) and ability to read and interpret chromatography
  • Knowledge of Microsoft Office programs and laboratory LIMS systems an asset
  • Ability to effectively work both independently and in a team environment
  • Superior time management and organizational skills
  • Experience with technical report writing and scientific documents an asset
  • Clear and concise written and oral English communication skills

 

COVID-19 Update:

We have adapted our recruitment strategy to ensure our staff and applicants are safe by conducting our interviews and onboarding online.

Other measures Apotex has put into place include (but are not limited to):

staggering employee shifts to reduce the size of work groups modifying our cafeteria space to enhance social distancing, the implementation of additional cleaning and sanitization routines robust self-assessment and screening tools non-surgical masks for employees working in GMP areas travel restrictions strict visitor screening protocol It is important to note that while these are our protocols at this time, they are subject to change based on guidelines and regulations put in place by local and global government agencies.

For up-to-date information about Apotex’s ongoing efforts in response to COVID-19, visit: https://www1.apotex.com/global/covid-19-update or follow us on LinkedIn and Twitter

 

 

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.   Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

 

More Information

Posted

Post Expires

Type

Executive / senior industry position

North%20York%2C%20Canada

North York , Canada