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, scheduling, coordinating, and tracking the testing and release of packaging components, raw materials, excipients and finished products, maintaining a 1 to 12 week scheduling horizon. Works closely with Supply Chain Execution, Production, QAIP and Quality Validation & Engineering departments to optimize the testing schedule, to minimize finished product release disruptions and to meet the testing cycle time. Responsible for accurately following the stability testing schedule. Where applicable, assigns raw materials or drug products testing in accordance with all in house, compendia, and regulatory requirements.
Demonstrates high level of engagement and organizational skills using advance understanding of capacity capabilities and limitations.
Serves as a working professional in the area of Laboratory Planning and Scheduling and shall be the primary contact for all related activities/issues. Understand cross site customers’ requirements to ensure their needs are met and supported. Responsible for resolving scheduling/planning conflicts with all stakeholders including but not limited to Production, QAIP, Supply Chain Execution.
Responsible for negotiating time to execute the required testing.
Responsible to review the proposed plan each week with the supervisors for the purpose of assigning work to the chemists. This shall be communicated to all affected groups to ensure full alignment of the business with the plan.
Assigns task to chemists, according to departmental schedules, instrument availability and training. Identifies priorities and make necessary adjustments if required.
Keeps track of instrument status and availability and cooperate with other departments for instrument and testing prioritization.
Prepares weekly schedules and task assignments to support Manufacturing activities under minimal supervision and ensure deadlines are met.
Prioritizes and keeps track of the external testing of samples.
Maintains track of the status of the testing for all incoming samples, including cleaning samples, validation samples, stability and special test requests.
Liaises with various departments, especially Supply Chain Execution, regarding testing challenges, scheduling of priorities, test failures. As required, informs all applicable internal parties within Apotex when date changes impact internal and external customer service.
Provides technical direction and support for troubleshooting problems with scheduled testing and required instrumentation. Identifies, recommends and implements opportunities for improvement of testing activities within QC.
Generates, maintains and monitors monthly metrics.
Lead special projects for continuous improvement within QC Chemistry department. Actively participate in workshops/transformations for highlighted process improvements
Utilize open, honest, two-way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving scheduling capabilities by personally seeking feedback and development.
Ensure adherence of team members with all compliance programs and company policies and procedures.
Works in a safe manner collaborating as a team member to achieve all outcomes.
Demonstrate Behaviours that exhibit our organizational Values:
Collaboration, Courage, Perseverance, and Passion.
Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
All other duties as assigned.
oCommunity College or University graduate in related discipline preffered
oWorking towards American Production and Inventory Control Society (APICS) certification is preferred
- Knowledge, Skills and Abilities
oExcellent organizational and interpersonal skills
oExcellent oral and written communication skills
oProject management experience and proficiency
oDemonstrates attention to detail, accuracy and timeliness.
oAbility to chair meetings
oKnowledge of operational supply chain processes including the flow of materials and information
oGood theoretical knowledge of analytical chemistry, including knowledge of IR, UV, HPLC, GC, AA, Auto Titrators, Dissolution, simple to complex Wet Chemistry Techniques, Nasal Spray testing techniques, etc.
oGood understanding of lab priorities and preferred experience in testing
oThorough understanding of GMP regulations
oFlexibility and ability to work in a fast-paced environment
oKnowledge of Change Control process in QMS Trackwise
oWorking knowledge of Microsoft Office (Word, Excel, Outlook, PowerPoint) is required
oThree to five years of progressive experience in analytical laboratory/pharmaceutical industry with majority of time in scheduling
oExperience with LIMS/SAP concepts and application
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.