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.
POSITIONS CURRENTLY AVAILABLE:
Sample Coordinator/Clerk – QC Department – 1 Year Contract Position
We have an opportunity for a 1 year Contract position for a Sample Coordinator/Clerk in our QC Department.
A self-starter with high energy and initiative, you have some background in science, good attention to detail, have an aptitude for using Word and Excel and documentation experience, preferably in a pharmaceutical setting. You must also have superior organizational, interpersonal skills and strong verbal and written communication skills.
Primary Purpose and Scope of Position is to ensure control of test samples. Log-in and tracking of samples is required. The Sample Coordinator/Clerk will also perform a variety of clerical duties for quality control staff, like collecting and compiling data from various samples, follow up on test status and interacting with subcontract labs to ensure work is done according to required timeline.
Duties will include:
Quality Investigation Specialist
We are seeking a highly experienced Quality Investigation Specialist who serves as the QA point-of-contact and/or QA lead for major non-conformance investigations. You should have a B.Sc. or in Chemistry or Microbiology, 5+ years Quality Assurance and Compliance experience in the pharmaceutical industry, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines, and strong verbal and written communication skills.
You possess extensive hand-on experience in leading and/or carrying out non-conformance investigations including risk assessment, root-cause analysis, and CAPA implementation. Your major responsibilities include authoring and/or critically reviewing investigation reports, perform internal trainings on investigation and CAPA, as well as interacting with regulatory agencies in audit settings.
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, 5+ years Quality Assurance and Compliance experience in the pharmaceutical industry, Sterility Assurance in a GMP environment, excellent knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines and strong verbal and written communication skills, experience interacting with regulatory agencies in an audit setting and correspondence is also required.
You will be responsible for improving and maintaining the GMP training program, participate in the self-inspection program, creating, reviewing and approving Standard Operating Procedures, reviewing and approving documents related to analytical testing, production, such as batch records and associated testing data, validation protocols, calibration records, stability programs, deviations, OOS documentation, trending, and document control.
Senior Analytical Chemist
As a Senior Analytical Chemist with a M.Sc. or Ph.D. in chemistry and 7+ years’ experience using HPLC and GC in the pharmaceutical industry, you are logical and have excellent oral and written communication skills. You have great accuracy and precision in all testing that you conduct and interpretation of analytical data and technical report writing are your forté.
You will be required to conduct the following:
Analytical Chemist, Research and Development
We are seeking a skilled Analytical Chemist, Research and Development with a M.Sc. or Ph.D. in Chemistry with 3+ years of experience with Method development and validation in Analytical R&D.
In this position you will be responsible for development and validation of analytical test methods for the product development. Key duties include design, development and validation of new analytical methods, protocols and reports write-up, draft specifications and other documents for regulatory submissions. Testing of R&D batches, raw materials and packaging components in accordance with GMP/GLP regulations may be required as needed. Work should be completed with little supervision/guidance in a timely manner.
To qualify for this position, the candidate must possess the qualifications:
Knowledge, Skills and Abilities:
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