Quality Control, Quality Assurance & Microbiology
Quality Control is responsible for sample testing to fulfil the quality requirements of Health Canada, FDA and International Regulatory bodies. Quality Assurance ensures that production materials meet quality specifications and are compliant with regulatory guidelines through our planned and systematic quality systems. The primary purpose and mission of the department is to analyze the microbiological nature and make-up of substances, using a variety of modern microbiological techniques, methods and instrumentation for its customers in a highly efficient, cost effective and timely manner.
The Microbiology department is involved in work as diverse as microbiological analysis, quality control, environmental monitoring and trending, microbiological support activities for sterile manufacture, microbiological method development and validation as well as microbiological support for manufacturing process development as required.
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.
Email:
POSITIONS CURRENTLY AVAILABLE:
Quality Assurance Associate
We are seeking a skilled Quality Assurance Associate with high energy level and initiative, You should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology, to 2-5 years Quality Assurance or Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs , US cGMP’s , FDA and ICH guidelines and strong verbal and written communication skills.
You will be responsible for maintaining and improving quality compliance, creating, reviewing and approving Standard Operating Procedures, reviewing and approving documents related to specification, analytical testing, production, such as batch records and associated testing data, validation protocols, calibration records, stability programs, deviations, OOS documentation, trending, and document control.
Director of Quality
At Dalton, our people are our greatest strength, and our success has been built on our technical capabilities and the way we manage our relationships with each other. Our culture is supportive and innovative, driven by some of the Industry's best and brightest people helping us make the impossible possible, compliantly. Are you at the point in your career where you are looking for an environment where you’re inspired to explore your passions, where your talents are nurtured and cultivated? Do you strive to innovate with leading-edge scientific technologies? If so, join our team of innovative drug developers working together to bring innovative, life changing discoveries to the global market. Dalton is a fast paced environment and has experienced tremendous growth in the recent years.
We are currently looking for an experienced Director of Quality to work in a pharmaceutical manufacturing environment to lead and manage the strategic and operational performance of the Quality, QC and Microbiology Departments, ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, while following to all regulatory compliance.
To qualify for this position, the candidate must possess the qualifications:
Duties would include, but not be limited to:
- Oversee operational activities in QA, QC and Microbiology areas to ensure timely completion of various of project tasks
- Establish and maintain Quality Systems and Procedures to ensure that the products and services are in compliance with cGMP requirements
- Host regulatory inspections and customer audits
- Prepare reports and other documentation required by regulatory agencies
- Establish, track and review quality performance indicators and trends
- Provide quality guidance and training
- Make a final decision about disposition of products
Education & Experience Requirements
- Minimum B.Sc. in a related science
- Strong leadership/team management skills.
- You must have excellent knowledge of the Canadian GMPs and FDA cGMP guidelines.
- 10+ years Quality Management (QA, QC, Microbiology) experience in the pharmaceutical industry
- Strong verbal and written communication skills
- Strong interpersonal skills
DOCUMENTATION REVIEWER
1 YEAR CONTRACT POSITION - 9:30 TO 6:00 SHIFT
As a Documentation Reviewer in the QC Department, you have a B.Sc. or M.Sc. in chemistry and 5+ years’ experience in conducting testing or reviewing analytical chemistry data in the pharmaceutical industry.
You are logical and have excellent oral and written communication skills. You have good familiarity with the documentation requirements for GMP production and GLP study support. You have great attention to detail in all work that you perform, and a quick mind for computations and trends. You are an expert at interpretation and evaluation of analytical data.
You will be required to understand and review data carried out using a wide variety of equipment including HPLCs with UV, DAD, ELSD and electrochemical detectors, GCs (including capillary column and headspace) with FID and TCD detectors, Karl-Fischer, UV-vis, FTIR, Osmometer, automatic titrators, pH meters, and wet chemistry analysis.
You will be required to actively participate in various aspects of development and validation programs, including the writing or review of Method Development Reports, Stability Studies, Validation Protocols and Validation Reports.
ANALYTICAL CHEMIST, LEVEL 1
We are seeking a skilled Analytical Chemist with a B.Sc. in chemistry and 2+ years’ experience using HPLC, GC, dissolution apparatus and automated titrators in the pharmaceutical industry.
You are careful in the laboratory have excellent oral and written communication skills. You have great accuracy and precision in all testing that you conduct.
Back to Job Postings