Quality Control, Quality Assurance & Microbiology

Quality Control & Quality Assurance

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. Thank you for your interest in working at Dalton Pharma. Please note that successful applicants will be notified by email within 2 weeks if they are selected for an interview. We do keep resumes on file. If we have an opening that better fits your career goals and experience, we will contact you.

Please forward your resume to:

Human Resources Department
Dalton Pharma Services Inc.
Email:

POSITIONS CURRENTLY AVAILABLE:


Senior Analytical Chemist

As a Senior Analytical Chemist with a M.Sc. or Ph.D. in chemistry and 7+ years of 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:

  • Testing using a wide variety of equipment including HPLCs with UV, DAD, ELSD, MS and electrochemical detectors, GCs (including capillary column and headspace) with FID and TCD detectors, Karl-Fischer, UV-vis, FTIR, oxygen headspace, Osmometer, automatic titrators, oxygen analyzers, pH meters
  • Carry out wet chemistry analysis.
  • Participation in development and validation programs.
  • Develop various methods for determination of different chemical entities and their properties, such as small molecules, peptides, proteins, DNAs and RNAs.
  • You may have opportunity to participate in project coordination, helping supervisor to oversee Analytical progress

Senior Quality Assurance Associate

We are seeking a skilled Senior Quality Assurance Associate with high energy level and initiative, You should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology, 3+ 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.

Responsibilities:
  • Write/ review and approve (as required) detailed quality investigations and provide support to production with root-cause analyses
  • Lead and provide guidance to Production and other departments with investigations
  • Coordinate with cross-functions teams for timely closure of non-conformances to ensure that corrective and preventive actions are initiated
  • Review and approve laboratory investigations in a timely manner
  • Perform investigation and closure of drug product complaints
  • Review and approve MBR/EBR of finished product /API of different dosage forms
  • Review and approve analytical data package for the final product batch release for both commercial and clinical products
  • Review and approve GMP Approved Vendor Forms, Master Batch Records, Master Work Sheets, Protocols, Change Controls, and Test Specifications
  • Prepare and review certificate of analysis for batch releases
  • Provide feedback to project managers customer inquiries relates to product releases for the assigned projects
  • Review and approve, validation protocols (Process/Sterilization/Cleaning/Equipment), calibration records and SOPs
  • Participate in Internal, Customer and Regulatory Audits
  • Perform self-inspection audits and assist in writing reports for internal and external audits
  • Provide backup to Quality Assurance Team Lead, as needed
  • Provide support to Quality Assurance Manager during regulatory audits
  • Train new employees in the Quality Department on the various known tasks
  • Perform special projects as directed by the Quality Assurance Manager and participate in process improvement initiatives
  • Provide compliance support to the project team
  • Issue change controls, deviations, CAPA, TAR, DNR and LIR reports, and EM-OOSs
  • Performs other related duties as required

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, 3+ 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.

Responsibilities:
  • Establish and maintain quality systems
  • Review and approve VQF, Master Batch Records, Master Work Sheets, Protocols, Change Controls, and Test Specifications
  • Creation of trend reports for Quality systems
  • Assist in the development of: SOP’s, test specifications, protocols
  • Follow up on biannual review of SOPs
  • Review and approval of executed batch records and worksheets
  • QA review and release of: raw materials, components and final products
  • Auditing functions: Assist in customer audits/regulatory audits (as a runner or as a scribe). Perform self-inspection audits and GMP spot-checks
  • Assist in the response to external audits
  • Customer contact during project initiation, follow-up (response to queries, request for changes)
  • Review and approval of Equipment Qualification Protocols/Calibration Certificates
  • Issue change controls, deviations, CAPA, Test Anomaly report and Laboratory investigation reports, and Environmental Monitoring OOS’s
  • Personnel Training – co-ordination of training activities such as SOP training
  • Administrative functions – attend meetings, timesheets, copying of documents for customers, creation of soft-bound logbooks, filing of GMP documents and archiving of GMP records
  • Performs other related duties as required

Quality Assurance Assistant 1-Year Contract

We are seeking a skilled Quality Assurance Assistant with high energy level and initiative; you should have a B.Sc. or higher degree in Chemistry, Biochemistry or Microbiology, preferably 1+ year experience in Pharmaceutical Quality Assurance is required. Experience in pharmaceutical industry, Sterility Assurance in a GMP environment would be an asset. Good knowledge of the Canadian GMPs, US cGMP’s, Health Canada, FDA, and ICH guidelines and strong verbal and written communication is also required.

Responsibilities:
  • Issuance of Change controls, deviations, CAPA, TAR and LIR reports, and EM-OOSs
  • Co-ordination with different departments for the finalization of SOP’s, test specifications and Analytical Methods including formatting of the documents
  • Update SOP binders and Table of Contents with new, revised and biennially reviewed SOPs
  • Perform all GMP activities in compliance with GMP guidelines & Dalton SOP’s (as applicable to duties)
  • Update Files & Archiving Files on Dalton’s administrative back-up filing system
  • Filing of Quality and Executed Operational Documents
  • Scanning of documents for clients as required and creation of soft-bound logbooks for the equipment and GMP process

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