MANUFACTURING - ENGINEERING
J. Edgar and Associates Inc. has been serving the Automotive, High Tech and Pharmaceutical arenas since 1992. We source Supervisory and support staff for Management, Engineering, Quality, and Materials. If you are currently in the market for a new employment opportunity, we invite you to view the current opportunities below.
PRODUCTION SHIFT MANAGER, cGMP Operations, to 95K, GTA
We are currently seeking a Production Shift Manager to coordinate shift activities in a cGMP and fully compliant pharmaceutical production environment.
As the Shift Manager, you will be responsible for performing some tasks and delegating others with the responsibility of follow up.
Main Duties include: Ensure production requirements are met to satisfy or exceed forecast demand, participate in the development and implementation of performance improvement strategies to increase productivity and improve quality, provide leadership and motivation to initiate creative thinking to support continuous improvement, evaluate activities of the set up mechanics and the technical processes to ensure production and quality demands are met, initiate training and development programs to improve performance on a continual basis. You will be called upon to recommend training as necessary to include technical, safety and cGMP’s as appropriate with overall responsibility for the efficient operations of the production areas. You will ensure the scheduled production as per the weekly production schedule is completed in a timely manner and provide sharing of production issues, progress and initiatives from one shift to the next to facilitate an efficient working environment. You will work with the other shift managers and the Director of Operations to determine the department budget and ensure the shift shop floor control processes are being monitored and closed at the completion of orders.
You must have experience with high speed packaging lines, c-GMP knowledge as related to compounding/packaging equipment design, operation and maintenance and computer literacy using BPCS, Microsoft Word, Excel, Scheduler, Project. We’re looking for someone with good mechanical aptitude. It is important to have the flexibility to work on different shifts and on weekends.
Solid investigation abilities including the ability to perform root cause analysis is essential as is good working knowledge and understanding of cGMP’s and compliance. The ideal candidate has strong interpersonal skills and ability to provide leadership and motivation. Strong communication skills, written and verbal, in order to communicate effectively with all departments and prepare documentation as required is essential.
A University degree in Science or Engineering is required with at least 5 years experience in a cGMP compliant environment including 3 years of Supervisory or management experience.
Salary range is $90-95K.
Call Jason Edgar for all the details at 416 225-2628, mailto:careers@jedgarcareers.com
We are seeking a Packaging Supervisor for our Pharmaceutical client to supervise operation of filling & packaging, to ensure that the highest possible product quality is maintained, while operating in a safe and efficient manner. This position reports to the Production Supervisor.
PRINCIPAL DUTIES AND RESPONSIBILITIES :
§ Directly responsible for: Line Leaders, Line Service Technicians, Line Operators, Production Technicians
§ Directly supervise packaging activities, ensuring close adherence to production schedule.
§ Ensure compliance with cGMP guidelines and SOPs, maintaining a high standard of housekeeping.
§ Review packaging work orders ( PWO ) and other product documents such as cleaning & sanitizing logs, housekeeping logs
§ Participate in scheduling activities with other members of the Operations group.
§ Ensure that equipment and facilities are maintained in a good state of repair arranging for corrective action when required.
§ Perform payroll and human resources functions such as managing E-time, hiring, coaching and disciplining. (Performance
Management).§ Ensure that all SOPs applicable/relating to Packaging Department are current and that all staff is trained in their use.
§ Ensure staff are working in a safe environment and that safety procedures are followed at all times.
§ Optimize labour utilization and productivity output to meet the goals of the department.
OTHER DUTIES AND RESPONSIBILITIES :
§ Investigate in-process, product and equipment failure identifying the root cause and corrective actions.
§ Maintain inventory of miscellaneous supplies and parts.
§ Support cross-training program
§ Participate in developing capital requirements for the department.
§ Will perform other duties as assigned.
KNOWLEDGE, SKILLS AND ABILITIES :
§ Knowledge of pharmaceutical manufacturing processes and equipment
§ Self-motivated and with a positive outlook
§ Good “people” and communication skills
§ Good organizational skills
§ Able to train and motivate crew
§ Mathematical, scientific and mechanical aptitudes
§ General computer skill; working knowledge of BPCS or other MRP program
BACKGROUND AND EXPERIENCE REQUIRED TO DO THIS JOB :
§ Degree or community college diploma in science or engineering technology.
§ Minimum 2-3 years in pharmaceutical manufacturing or related fields.
§ Strong pharmaceutical cGMP background.
§ Management/supervisory skills.
§ 5- Safety practices, including WHMIS
PROBLEM SOLVING :
Issues may include the following: Equipment malfunction
· Ensuring consistent product quality
· Manpower and equipment “bottlenecks”
· Resolving personnel issues, while maintaining department goals
The Packaging Supervisor must be a resourceful person to identify available resources to help or assist him in dealing with some of the issues/problems. Available resources may include: Production Manager. Compounding Manager, staff from other support departments like QC, Tech Services, etc., SOPs, historical data, etc.
WORKING CONDITIONS:
§ Maybe contacted through telephone during off regular hours regarding “urgent” or emergency issues.
§ Exposed to noise from equipment.
§ Work overtime, including weekends, when required.
§ Ability to “ juggle “ a number of tasks at the same time, multi tasking.
§ This is an afternoon Tuesday to Saturday shift.
Call Cris Murray 416 225-6386, mailto:jedgar@sympatico.ca
We are currently seeking a capable Quality specialist to manage and direct the activities of Microbiology, Validation, Compliance, QA, and Technical Services in a large pharmaceutical Manufacturing environment.
As Leader for the Group, you will be responsible for the direct management of QA, QC and Compliance groups while assisting and motivating all departments cross-functionally. You will be called upon for leadership for HPB/FDA audits as well as the regulatory awareness programs for each agency. Assisting in the development of cGMP and GLP policies for all departments, you will lead the FDA and HPB audit response teams.
You must have at least 5 years of experience in Quality Operations management to be able to maintain monthly reports, departmental budgets and complete reviews of appropriations. The Director of Quality Operations will also provide technical support to Pharmaceutical Sales, Client Services, PDS, Operations and individual clients.
You must have a B.Sc. in Chemistry, Pharmacy, Microbiology or a related science with a minimum of 5 years in Senior Quality management within big Pharma. Extensive FDA audit and audit response experience is required.
Salary is in the $115-130K range. Bonus and full benefits apply.
Call Jason Edgar at 416 225-2628 mailto:careers@jedgarcareers.com
We are currently seeking an experienced Industrial Engineer who has managed
and coordinated the production schedule for contract maintenance in a food or pharmaceutical manufacturing setting.
The position is responsible for the execution of weekly and monthly schedules for each packaging line. Creating an efficient schedule
with maximizing output by managing operating costs is a big part of the position.
Other Duties:
- Responsible for creating weekly packaging schedule.
- Review shortage report and confirm availability of material.
- Create a constraint/ exception report.
- Communicate weekly frozen schedule
- Communicate the shortages or critical items required to execute the plan to QA/QC, purchasing and warehousing
- Responsible for organizing contract manufacturing.
- Create shop packets, shipments to the vendors, confirm delivery dates
- Attend daily production meetings with QA/QC, operations
· To assist Shop floor coordinator to create shop packets
· To hold meeting with Contact manufacturers to communicate commitments
· To work with the Packaging Engineer to confirm validation and exhibit batches status.
Requirements:
University degree or diploma in Industrial Engineering.
2-3 years experience in scheduling and planning in Food or pharmaceutical industry. APICS designation or enrolled inventory
Salary is in the $60K to $ 65K range.
Call Cris or Jason at 416 225-6386 for full details, mailto:jedgar@sympatico.ca