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:

Microbiology Manager

As the head of Microbiology team, the Microbiology Manager will be responsible for the overall operation of the department dynamic that plans and executes microbiology related tasks and activities according to project scope of work, deadlines and budget.

The successful candidate should meet the following qualifications and requirements.

Qualifications and Requirements

  • Working closely with internal teams and suppliers, the Manager, Microbiology will provide leadership in establishing and maintaining the corporate quality systems and standards.
  • Strong understanding and sound interpretation of the Canadian GMPs, FDA GMPs, Medical Device Regulations, ISO, and other related guidelines.
  • Proven track record of leading a high performing Microbiology team, including scheduling team workloads, setting priorities and meeting deadlines.
  • At least 7 years working experience in Microbiology in an aseptic GMP environment, with minimum 5 years in increasing supervision/management position.
  • Strong Quality and risk-based approach decision making.
  • M.Sc. in a Microbiology degree.
  • Commercial experience preferred
  • Strong verbal and written communication skills

QA Manager

The QA Manager will be responsible for managing all quality activities within to ensure departmental compliance with cGMP and to provide quality oversight and support for facility, manufacturing, and analytical laboratory.

The successful candidate should meet the following qualifications and requirements.

Qualifications and Requirements

  • Working closely with internal teams and suppliers, the Manager, Quality Assurance will provide leadership in establishing and maintaining the corporate quality systems and standards.
  • Strong understanding and sound interpretation of the Canadian GMPs, FDA GMPs and other related guidelines, Medical Device Regulations, and Controlled Drugs and Substances
  • Proven track record of leading a high performing QA team, including scheduling team workloads, setting priorities and meeting deadlines.
  • Strong Quality and risk-based approach decision making.
  • Oversee HC, FDA, client, and supplier audits to ensure regulatory compliance.
  • Quality Auditor Certification and audit experience an asset
  • Proficient in managing deviations, root cause analysis, and CAPA implementation.
  • Strong planning, organizational and people skills.
  • B.Sc. in a related science, e.g., chemistry, microbiology. Microbiology course(s) at the university level are required.
  • At least 7 years working experience in pharmaceutical quality, and minimum 5 years in supervision/management position.
  • Strong verbal and written communication skills

SENIOR ANALYTICAL CHEMIST, METHOD VALIDATION

We are seeking a skilled Senior Analytical Chemist with a testing as per compendia general chapters and  product-specific methods, using  analytical instruments, including HPLC,  GC, UV, FTIR, KF titrators, potentiometric titrator, DSC in R&D or QC setting 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 strength.

In this position you will be primarily responsible for:

Knowledge, Skills and Abilities:

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.

  • Working closely with internal teams and suppliers, the Manager, Quality Assurance will provide leadership in establishing and maintaining the corporate quality systems and standards.
  • Strong understanding and sound interpretation of the Canadian GMPs, FDA GMPs and other related guidelines, Medical Device Regulations, and Controlled Drugs and Substances
  • Proven track record of leading a high performing QA team, including scheduling team workloads, setting priorities and meeting deadlines.
  • Strong Quality and risk-based approach decision making.
  • Oversee HC, FDA, client, and supplier audits to ensure regulatory compliance.
  • Quality Auditor Certification and audit experience an asset
  • Proficient in managing deviations, root cause analysis, and CAPA implementation.
  • Strong planning, organizational and people skills.
  • B.Sc. in a related science, e.g., chemistry, microbiology. Microbiology course(s) at the university level are required.
  • At least 7 years working experience in pharmaceutical quality, and minimum 5 years in supervision/management position.
  • Strong verbal and written communication skills
    • Validation of new analytical test methods, method transfers, method verifications for small molecules, peptides, proteins, DNAs and RNAs, including some method development.
    • Writing test methods, SOPs, validation protocols and reports.
    • Adhering to ICH, GMP/GLP/GDP regulations, ALCOA and Data Integrity.
    • Remaining within the project scope (time and other restrictions)
    • Use of a variety of equipment including HPLCs, GCs with various detectors, UV-vis, automatic titrators, pH meters, etc.
    • Some testing of Drug substance and Drug product batches.
    • Independently use available literature and resources to transfer, validate or develop novel methods.
    • Planning and organizing multiple tasks and working independently.
    • Training other analysts.
    • Superior theoretical and practical knowledge of organic, inorganic, physical and analytical chemistry including in-depth knowledge of gas and liquid chromatography, spectroscopy and other analytical techniques employed in the pharmaceutical development
  • 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

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