Quality Control & Quality Assurance

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

Laboratory Systems Support Specialist

Overview:
Provide local laboratory informatics support including Agilent OpenLAB, QMS system, instrument integration applications, lab reporting tools, OpenLAB templates for new methods, lab software problem solving and new instrument software qualification.

  • Provide Compliance Support by participating in Creation and Validation of Systems and Spreadsheets.  Engage in activities to ensure the compliance of instruments and testing meet regulatory requirements.

    Skills:
    • Advanced Knowledge of OpenLAB and Excel.
    • Functional Knowledge of Lab Instrument Software, Lab Practices and Lab Data Quality Procedures.
    • Ability to Leverage Emerging Technologies to Improve Lab Operational Efficiency.
    • Comprehensive understanding of data integraty requirements and best practices.
    • Experienced as a SME in participating regulatory inspections
    • Ability to communicate technical information both verbally and in written reports that is understandable by technical and non-technical audiences; to produce report of results and recommendations that is clear and concise.
    • Build technical relationships.
    • Train and instruct analysts/scientists. Provide assistance to analysts/scientists.
    • Engage in daily contact with key laboratory personnel e.g. Lab managers, other team members, understand lab workload, priorities and other pertinent information.
    • Communicate with relevant stakeholders such as IT Services and other Technical Functions, and vendors/suppliers, providing information on laboratory needs, performance testing results, other facts.
    • Gather information from IT Services and others to help understand impacts on lab operation.
    • Ability to read, write and speak the English language is required.

Qualifications:
M.Sc. or B.Sc. with relevant experience

Years of previous work experience desired:
2-3 years relevant experience with Lab Informatics with M.Sc.

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. 

Analytical Chemist, Level 3

We are seeking a skilled Analytical Chemist with a M.Sc. or Ph.D. in chemistry and 5+ years’ experience using HPLC with a variety of detectors (including UV, RI, ELSD), GC-FID, TOC, IC, SEC-MALLS,

Electrophoresis, Dissolution Apparatus, Particle Size Determination and automated titrators in the pharmaceutical industry.  You are logical and have good knowledge of method development and method validation requirements.

You are experienced at writing technical reports 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.

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