Manufacturing Operator - Level 1 - CAD

Description

In accordance with established policies, directives, procedures, manufacturing sheets and in compliance with Good Manufacturing Practices, preventive health, safety and environmental measures and the business procedures/processes of the Montreal Site, the main tasks of the manufacturing operator are:

Member of the process-focused team, the manufacturing operator is responsible for manufacturing various dosage forms and performing the different process steps such as weighing, granulation, mixing, compression, encapsulation, coating and inspection of solid, semi-solid or liquid dosage forms according to his professional specialty, respecting the different criteria in the different dimensions: Safety, Quality, Execution, Costs and People.

To clean and maintain accessories and equipment in his sector as well as in his workplace.

To carry out the production step under his responsibility, to carry out the required inspections and controls and to document his actions, according to the manufacturing sheet and the standard work charters.

B.MAIN RESPONSIBILITIES / Major Responsibilities
The following tasks are carried out in accordance with established policies, directives, procedures, manufacturing sheets and in compliance with Good Manufacturing Practices, health, safety and environmental protection measures, Montreal Site business procedures/processes as well as standard work.

Level 1
(The level 1 operator will be asked to perform a grouping of tasks among the following tasks)
1. Cleaning (different types of cleaning) of certain rooms, rooms (floors, walls, sinks etc.), containers and its work area
2. Dismantling, cleaning and assembly of production equipment according to procedures and GMP following the standard working methods established where appropriate
3. Cleaning planning to optimize production schedules and the use of cleaning rooms
4. Verification of the condition of parts and/or equipment for cleanliness as well as for the general condition of the part and/or equipment
5. Running of certain production equipment
6. Execution of clearances of rooms or sections
7. Evaluation of the quality of equipment and products
8. Documentation (manufacturing sheet, records, cleaning labels, standard work charters etc.) adequate, according to GMP rules and verification of documentation
9. Printing and/or inspection of tablets or capsules according to
10 standards. Execution of preventive maintenance (TPM)
11. Punch polishing
12. Waste management (garbage and/or pharmaceutical waste)
13. Parts storage
14. Follow-up of requests with specialists or supervisors
15. Handling of certain equipment and products (powder, cores, tablets)
16. Verification of raw materials
17. Execution of sanitation tasks
18. Execution of certain reconciliations
19. Maintenance of an adequate inventory of certain products and/or equipment and/or supplies
20. Occasional replacement of Operators 2
21. Identification of problems and proposal of solutions
22. Participation in T0 T1 meetings and the Q1 23 continuous improvement loop
. Training of colleagues
24. Active participation in the continuous improvement program and mention of ideas via the 25 t-card system
. May be called upon to participate in team committees if required (e.g. HSE, operational excellence, CCM, special projects, job evaluation etc .....)
26. May be called upon to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.)

Level 2 (May be called upon to do Level 1 tasks on occasion)

1. Weighing, granulation, mixing, compressing or coating of solid dosage forms or manufacture of ointments, creams or liquids in accordance with the manufacturing sheets
2. Follow-up of manufacturing instructions and parameters in the manufacturing sheet and documentation
3. Execution of controls during production
4. Verification, calibration and calibration of instruments and equipment
5. Verification, calculation of certain adjustments (pH, volume)
6. Transactions in certain it systems (e.g. SAP)
7. Management and proper use/selection of defects
8. Monitoring and documentation of product parameters and quality
9. Documentation (manufacturing sheet, records, cleaning labels, standard work charters etc.) adequate, according to GMP rules and verification of documentation
10. Handling of powder, cores, tablets, capsules, liquids and/or semi-liquids
11. Cleaning and running of production equipment
12. Reconciliation
13. Optimization of production parameters within the permitted limits
14. Production monitoring
15. Preparation of bulk for packaging
16. Segregation and proper identification of toxic containers and pharmaceutical waste
17. Palletizing raw materials
18. Physical inventory of certain raw materials
19. De-exemption from certain raw materials
20. Loading and unloading of certain equipment
21. Work planning
22. Training of colleagues
23. Participation in T0 T1 meetings and the T1 continuous improvement loop.
24. Follow-up to standard work charters
25. Active participation in the continuous improvement program and mention of ideas via the t-card system
26. May be called upon to participate in team committees if required (e.g. HSE, operational excellence, CCM, special projects, job evaluation etc.....)
27. May be called upon to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.)

Level 3 (May be called upon to do level 1 or 2 tasks on occasion)
1. Sees to the improvement of performance and standard work by using continuous improvement approaches and tools
2. Acts as a leader by using continuous improvement tools and evaluating value-added activities
3. Mobilization of the process-focused team to achieve the quarter 4 production target
. Facilitator and resource person in team
5. Support and assistance to the team in order to meet the objectives of the team
6. Coordination of work organization and resources
7. Problem anticipation, problem solving resource
8. Close collaboration with supervisors
9. Documentation (manufacturing sheet, records, cleaning labels, standard work charters etc.) adequate, according to GMP rules and verification of documentation.
10. Communicating expectations to the team
11. Short interval checks
12. Participation in T0 - T1 meetings and the T1 13 continuous improvement loop
. Ensures that relevant information cascades to the next quarter
14. Solicits and manages ideas from his colleagues, he must promote the system of t-cards
15. Training of colleagues
16. Active participation in the continuous improvement program and mention of ideas via the 17 t-card system
. May be called upon to participate in team committees if required (e.g. HSE, operational excellence, CCM, special projects, job evaluation etc .....)
18. May be called upon to perform training follow-up tasks (updating training curricula, associating modules, updating procedures, etc.)

C.EDUCATION, DIPLOMAS, BACKGROUND EXPERIENCE / Education, Certification, Previous Experience
High school diploma or equivalency
Knowledge of GMP (an asset)
2 years of experience in the pharmaceutical or related field (an asset)
Mechanical skills and computer knowledge

D1. NUMBER OF DIRECT SUBORDINATE STAFF N/A

D2. Total Subordinate Staff Level 3: between 8 and 15

D3. RESPONSIBILITIES - Employee management responsibilities N/A
Level 3: Acts as Resource Coordinator

E. COMPLEXITY OF PROBLEMS, DECISION-MAKING / Problem Complexity, Decision Making
Levels 1 to 3
Very frequent Decision-making on the quality and integrity of products according to manufacturing procedures and sheets
Solving problems encountered in its tasks
Decision-making related to the management of priorities
Frequent / Frequent Evaluation of the types of cleanings to be carried out
Evaluation of parts, see if maintenance or replacement is necessary
Execution of different calculations (e.g. reconciliation, pH adjustment etc.)
Level 3
Very frequent / Very frequent Prioritization of human and material resources, taking action during deviations in order to reach the production plan, application of continuous improvement concepts and dealing with the human factor.

F. INITIATIVE AND CREATIVITY / Initiative and Creativity
Levels 1 to 3
Very frequent / Very frequent Optimal palletizing of raw materials for certain tasks
Frequent / Frequent Organization of their time to optimize production sequences
Occasional / Occasional Participation in continuous improvement projects (HSE, quality, efficiency)
Participation in investigations during a deviation
Level 3 Very frequent Maintenance and improvement of standard work
Taking the initiative necessary to achieve production objectives

Last updated on Sep 6, 2022