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.
Responsible for planning and executing cleaning validation activities in accordance with FDA, HPFBI, EMA, and ICH’s guidelines and applicable Apotex policies and processes.
Liaises with key business members to generate CV Product and Equipment Risk Assessment reports, when evaluating new and / or changes to product formulations and manufacturing equipment to assess if Cleaning Validation Protocol studies are required.
Generates Cleaning Validation protocols / studies, and subsequent reports. In developing these studies, sampling requirements and acceptance criteria are selected to represent worst-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 event activities (sampling, cleaning, testing requests) with the assistance of production / packaging as required.
Executes cleaning validation / verification events : LIMS project generation and sampling preparation, Perform visual inspection and sampling of equipment, Delivers samples to the laboratory, and Complete LIMS and / or visual inspection form result entry and electronic filing of completed results.
Reviews lab results for compliance to validation protocol acceptance criteria, updates the appropriate tracking and filing systems, communicates results for equipment release, and summarizes data for validation reports.
As necessary, evaluates, maintains and orders sampling supplies.
Recommends changes to equipment cleaning procedures and sampling methods to allow for successful completion of cleaning validation studies.
Provides coaching to technicians and operators involved in cleaning validation activities.
Provides presentations on validation topics as required to Validation team members, and potentially to outside departments and organizations.
Initiates and recommends changes to SODs, and master documents pertaining to cleaning validation.
Performs impact assessment, in conjunction with the management team, for proposed changes to production equipment and cleaning procedures on the validation program using the appropriate change control procedures.
Provides technical assistance, in conjunction with the management team, related to validation to outside suppliers and various departments and divisions within Apotex.
May sit on necessary project teams as required.
Communicates project status updates to management through the use of tracking sheets (Excel or MS Project).
Performs other related duties as assigned.
Bachelor’s degree in Science or Engineering is preferable.
Minimum of 5 years pharmaceutical industry experience or 2 years validation experience.
Demonstrated knowledge of cleaning validation concepts.
Proven organizational, risk management, problem solving, and project and time management skills demonstrated by previous work experience, in order to manage multiple priorities in a fast paced environment.
Excellent English oral and written communication skills are a must. Strong technical writing skills are required.
High level of familiarity with Microsoft Office (Excel, Word) is required. LIMS experience is an asset.
Must be able to excel both within a team environment and independently.
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.