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:

QMS Compliance Specialist

As a QMS Compliance Specialist in the QC Department, you have a Bachelor of Science degree in Chemistry and or in Biological Sciences or equivalent in experience or training with 5 or more years experience in a quality control documentation setting in a pharmaceutical company.

You will be required to conduct the following duties:

  • Administering, maintaining, and improving the site quality management system (QMS) to meet the requirements of the corporate quality management program.
  • Responsible for all aspects of technical support related to the eQMS system and associated applications. This includes, but is not limited to, end-user support (help desk), issue resolution, password resets and user account management.
  • Responsible for maintaining the Global eQMS system and performing tasks related to continuous improvement of this system and all its modules.
  • Review and Approve Computer System Validation documents related to the eQMS system(s) such as; Functional Requirement Specifications, Validation Summary Reports, Risk Assessments and Pre/Post-Executed Test Scripts.
  • Document, Train, and coach other departmental personnel to perform basic administrative functions of the eQMS system(s).
  • Responsible for creating and maintaining user-profiles and security roles and the ability to provide audit reports on-demand to meet business and regulatory requirements.
  • Review changes to the validated state of the system through the change control and participate in planning and implementing changes
  • Monitor systems and databases to ensure uptime and quality.
  • Enters and manages Incident, Change and Service Request tickets in Service Desk Express, IT Service Management Application.
  • Perform system copies, TEST, VALIDATION, PRODUCTION and database refresh activities.
  • Conduct periodic review and audits of Quality Systems

Additional Tasks

  • Review data generated by Lab Support including trending reports and protocols.
  • Review and interpretation of data generated by the Lab Support, in the assessment and investigation of anomalous results and must ensure that the data is correct, accurate and its quality meets requirements (GMP, Regulatory and Dalton internal) prior to submitting it to QA in a timely manner

Qualifications:

  • Education: Bachelor of Science degree in Chemistry and or in Biological Sciences or equivalent in experience or training.
  • Experience: 5 or more years experience in a quality control documentation setting in a pharmaceutical company
  • Comfortable with Salesforce
  • Candidates with demonstrated analytical experience and documentation experience will be preferred.
  • Demonstrated technical analytical and computer expertise and a broad understanding of cGMP, ICH, FDA guidelines.
  • Solid interpersonal and technical writing skills.
  • Candidates must be proficient in using various types of computer software (Word, Excel. PowerPoint & Outlook);
  • Proven ability to manage and coordinate multiple projects in a fast-paced, highly professional environment

QC Documentation Reviewer

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.

Senior Analytical Chemist

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.

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:

  • Testing 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, 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 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. Experience in setting up Specification would be a priority.

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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