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Apotex - Etobicoke, ON

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Responsible for preparing experimental and small scale production batches and performing experimental trials to demonstrate the effects of changes to formula and/or manufacturing process for existing products. Perform process troubleshooting, optimize processes, and participate in product investigation. Participate in equipment set-up operation and cleaning. Monitor the execution of the validation/stability/launch batches. Summarize, evaluate and interpret in-process and analytical data. Write technical, observation and summary reports. Working and ensuring that all operations are performed in accordance with SOP, GMP, SWP and all company policies and regulations. (Experience in 4-8 functional areas)

Job Responsibilities:
1. Records observations on product and process characteristics during experimental trials and production batches, for example powder flow, capping, sticking, binding, filming, picking, etc. as required.

2. Completes and signs-off on all formal process documentation required for the production of trials, pilot and small-scale batches.

3. Technician is proficient at basic skills in New Product Launch, and builds on more advanced skills required for optimization of processes and troubleshooting required to support activities in New Product Launch.

4. Prepares pre-formulation, experimental, ANDA, optimization, and scale-up trials and batches as per approved project plan, protocol or master formula.

5. Assists with the production of bio / submission batches.

6. Dismantles, cleans, sanitizes and assembles, as required, F.D. rooms and equipment according to established SOPs and Technical Manuals to ensure GMP compliance and meet schedule requirements.

7. Recognizes out of normal situations and uses conventional problem-solving skills to identify the root cause and troubleshoot problems, provides feedback to the supervisor, and seeks assistance as required.

8. Assists more junior technicians and provides guidance on basic issues as required.

9. Assists, as required, with troubleshooting and training on manufacturing and F.D. equipment and processes.

10. Reviews trial and batch documentation for correctness and completeness before forwarding to Documentation Team.

11. Deducts raw materials from inventory where required.

12. Performs other related duties as assigned.

13. Weighs, mixes, screens and blends raw materials to produce experimental trials, pilot and small-scale batches for compressed, enteric coated, and film-coated tablets, capsules, pellets, powders, liquids and others as required.

14. Sets-up and cleans all equipment including tablet presses, capsule fillers, oscillators, coating pans and air jet mills, etc. as required.

15. Expert knowledge of basic processes and techniques on equipment used in New Product Launch.

16. Builds on skills required for optimization of equipment used at key processing steps in the manufacturing process.

17. Troubleshoots common problems with equipment.

18. Performs in-process quality tests on trials and batches for weight, hardness, thickness, friability, disintegration, etc. as required.

19. Recognizes out of normal situations and solves basic process problems. Assists Scientists or Technologists when required and performs any related duties as assigned.

20. Recommends modifications to methodology used in trials and optimization where there are opportunities to improve processes / procedures.

21. Assists in the investigation of process deficiencies for trials and pilot batches being manufactured in order to determine the causes and to recommend solutions for improvements.

22. Provides feedback on formulations and manufacturing process changes for pre-production batches to optimise formulation and facilitate efficiency improvements.

23. Applies problem solving skills and utilizes all available resources to correctly identifies process and / or formulation deficiencies and proactive in implementing a solution.

24. When unable to resolve problem escalates to senior co-worker for making decision.

25. Able to work with minimal supervision.

26. Able to handle more than one project at a time as demonstrated through inter-departmental or departmental training.

27. Provides assistance to all New Product Launch Technicians in the department as required.

28. Facilitates the exchange of information through focus groups, department meetings, presentations and training.

29. Provides training to Technicians as directed by Supervisor.

30. Ensures that all work is performed in compliance with current Good Manufacturing Practices (GMP), Standard Operating Procedures (SOP) and established Safe Work Practices (SWP).

Job Requirements/Education/Competencies:
This position is located at our Signet location at Weston Rd. and Steeles.


Apotex - 3 years ago

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