Student- Coordinator, Cleaning Validation, Etobicoke, 4 Months

Date: May 14, 2019

Location: Etobicoke, ON, CA, M9W 6Y3

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

Requirement 

Must currently be enrolled in a Co-op Program. 

A Day in the Life…

  • Attend daily departmental meetings to establish priorities to support business needs.
  • Research scientific libraries (i.e. USP, Merck, Product Monographs, etc.) to determine product cleaning characteristics and write risk assessments that establish if a product will be worst-case for cleaning.
  • Work with Production, Laboratory and Cleaning Validation teams to execute surface swab sampling of manufacturing equipment.
  • Work with validated computer systems (LIMS, SAP) to coordinate sampling events and results recording.
  • Work with Cleaning Validation Management to complete equipment and/or product change assessments to document impact to validation.
  • Update departmental trackers and communicate project status to management in Cleaning Validation and Production.

Job Responsibilities

  • Prepares and/or reviews all risk assessment reports, protocols, and reports related to cleaning validation.  In developing these protocols, products and sampling locations are selected to represent worse case conditions and the sampling and testing criteria are designed for world-wide regulatory compliance (FDA, HPFBI, EC and ICH standards).
  • Co-ordinates the cleaning validation activities (sampling, cleaning, testing requests) with the assistance of production/packaging as required.
  • Recommends changes to equipment cleaning procedures and sampling methods to allow for successful completion of cleaning validation studies.
  • Reviews, initiates and recommends changes to SODs, and master documents pertaining to cleaning validation.  Reviews the impact of proposed changes to SODs and master documents with respect to the validation/qualification status of equipment cleaning procedures.
  • Reviews and assesses, in conjunction with the Supervisor, impact of proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
  • In conjunction with the Project Leader, communicates project status updates to management through the use of tracking sheets (Excel or MS Project).

Job Requirements

  • Must be enrolled in a recognized post-secondary Co-op education program (Engineering or Science).
  • General computer skills and comfort with Microsoft office products required.
  • Well-developed communication (both oral and written) and interpersonal skills. Technical writing experience is an asset.

 

 

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.

 

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