Our highly specialized Manufacturing and Operations department completes the technology transfer from Research & Development for the GMP manufacturing of Active Pharmaceutical Ingredients (APIs), sterile and solid finished dose drug products.
We are always looking for new people to contribute to the company's growth. We offer a competitive salary and benefits and an excellent opportunity to build your career with a growing company.
Please forward your resume to:
Human Resources Department
Dalton Pharma Services Inc.
POSITIONS CURRENTLY AVAILABLE:
GMP OPERATOR (STERILE)
Dalton Pharma Services is looking for results-driven dedicated individuals, who are problem solvers and team players.
This position requires shift work: typical hours of work are Monday to Friday 2:30 p.m.-10:30 p.m., occasional weekend work is required.
Candidate Education and Experience:
- Minimum three (3) year College Diploma (Pharmaceutical Technology or Biological Sciences), plus a minimum of one (1) year of previous relevant work experience within other pharmaceutical or biotech firms.
- Previous production experience in a GMP environment, drug manufacturing including in formulation, filling, and manual or semi-automatic visual inspection (optional) is required; aseptic manufacturing experience in a clean room environment is an asset including media fills.
- The successful candidate will have excellent command of English, both verbal and written communication skills, mathematical skills, with the ability to work in a team environment. Must be able to follow written and verbal instructions
- Demonstrated ability to work independently and make quick decisions in accordance with SOPs and training.
- Basic computer skills and the ability to enter and maintain accurate data and in a timely manner.
Member of a team in GMP Operations must possess:
- Knowledge of GMP, understanding of pharmaceutical Quality Systems, understanding of reagent SDS, PPE, and Health & Safety (including machine safety)
- Knowledge of aseptic practices: sterile gowning, cleaning/cleaning reagent preparation, operating of machinery in Class 10,000, Class 1,000, and Class 100 fill rooms, and media fills.
- Good knowledge of basic Microbiology
- Troubleshooting and problem solving capabilities
Member of a team in GMP Operations routine job duties will include:
- Perform all GMP activities in compliance with GMP guidelines & Dalton Pharma Services SOP’s
- Accomplishing all tasks involved in completion of assigned GMP projects
- Cleaning GMP production area using qualified cleaning agents*, cleaning reagent preparation
- Do line clearance prior and post cleaning
- Filling data, calculations, activity, etc. in MBR as task performed or verified
- Participate in peer review of data, calculations, activity, etc. in MBR
- Understand setup and running of Filling Line/s and associated computers/printers, and other sterile process operations (filtrations/formulations/crystallizations)
- Train personnel on job
- Environmental monitoring of personnel, in the filling line rooms, recording temperature and relative humidity measurements
- Identify products properly to go in fridges, retrieve products from fridge where required
- Retrieve components from warehouse and return to warehouse filling in Material Requisition Form, MBR
- Understand incident reports and ensure GMP compliance
- Perform components processing and filling in MBR. Enter information in computer system if required.
- Control and maintain inventory of sterile material and equipment
- Maintain equipment in good condition, report unusual events, sounds, smells, etc.
- Clean machines, set up scales
- Understand environmental monitoring equipment and take appropriate action when there is an alarm
- Report when small equipment needs calibration or replacing
- Constantly look out and report actions that can prevent defects, downtime, and equipment failures
Member of a team in GMP Operations – team duties and responsibilities
- Attend team meetings, group training, company meetings
- Good time management of activities, planning of personnel relief, identifying the need for additional staff and / or overtime to maintain production and communicating to supervisor
- Good time management for personal gowning qualification, intervention tracking for media fills, SOP self-training, other documentation self-training
- Train new members of a team.
*Notify HR upfront regarding known cleaning agent allergies, not being able to wear a full-face mask, or any other medical condition that may impede cleanroom work
GMP Operator (API)
We are seeking a skilled Chemist with 3+ years pharmaceutical experience in manufacturing Active Pharmaceutical Ingredients.
You have a minimum of a BSc in Chemistry with demonstrated experience and skills in synthetic organic chemistry. Preference will be given to candidates with industrial experience or synthetic organic chemistry backgrounds.
You are familiar cGMP guidelines. You will be involved in the set-up, operation and cleaning of our production equipment and suites. You will manufacture chemical products according to the highest standards of quality and safety. You must be willing to work with hazardous chemicals and chemical processes from multi-gram to multi-kilo scale. Occasional late shift and weekend shifts may be required.
While we appreciate all applications received, only those selected for an interview will be contacted.
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