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:

Site Head of Quality Opportunity

Dalton has experienced tremendous growth in recent years developing and manufacturing complex pharmaceutical products in a highly regulated environment. We have an excellent history of Health Canada Establishment Licencing Inspections, and we are currently looking for a Site Head of Quality with demonstrated experience and technical knowledge in Sterile Pharmaceutical Manufacturing for global markets. The position entails working in a fast-paced pharmaceutical research and manufacturing environment leading and managing the strategic and operational performance of the Quality Unit, including QA, QC and Microbiology Departments. The successful candidate will work with the leadership team to successfully execute on our business strategy, achieve Key Performance Indicators (KPIs) and objectives, while maintain regulatory compliance as part of the Seikagaku Group of companies.

Major Responsibilities:

  • Provide leadership to Quality Teams (QA/QC/Microbiology) through employee development and performance management as well as establishing a culture of Quality.
  • Provide leadership for the development and maintenance of processes enabling effective execution of the key Quality Systems and Procedures to ensure compliance to cGMP and regulatory commitments including:
    • Quality Management Systems
    • Risk Management Programs o Development and implementation Standard Operating Procedures (SOPs)
    • Third-party audits and self-inspection program
    • Oversight of the Product Quality Complaint Program
    • Provide direction on Investigations (Deviations, OOS, Laboratory Investigations) Management; Corrective Action and Preventative Actions; and Change Control related to QMS.
  • Oversight and maintenance of Drug Establishment License(s).
  • Prepare executive summary of quarterly quality review.
  • Ensure adherence to safety, ethical compliance standards.

Knowledge, Skills, and Experience:

  • Minimum B.Sc. or related science degree, including university courses in Microbiology.
  • Over 10 years’ quality management experience in pharmaceutical industry with a strong background in aseptic processing and sterile product manufacturing.
  • Have been leading quality teams of significant size, including QA and QC.
  • In depth knowledge of cGMP, FDA, EMA, HPFBI Regulatory requirements (Drug and Medical Device) and the associated guidelines. PDMA knowledge would be a strong asset.
  • Experience in leading regulatory inspections (FDA/HC) and client audits.
  • Proficiency in guiding investigations and managing CAPA program.
  • Strong management skills to drive competency and present information at all levels internally and externally.
  • Excellent leadership skills in coaching and building high performance teams.
  • Previous working experience in CDMO environment is preferred.

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