qa / qc associate (pharmaceutical)

2 weeks ago

Vaughan ON LL H, Canada Jaapharm Canada Inc. Full time $60,000 - $75,000 per year

Jaapharm located near Hwy. 7 & Weston Road specializes in solid dosage pharmaceutical products, in-house research, manufacturing, packaging and testing. 80% of total budget in R&D, relates to analytical chemistry method development and compression process development, at present.

Founded in 1988, Jaapharm's focus is directed towards the research in compression (tablet) & analytical method validation for raw material & finish products relating to compression.

Q.A. / Q.C. ASSOCIATE

Assists in providing oversight and on-going development of QA System updates, QA In-Process, QA reference to Sanitation Control procedures, the Quality Assurance relating to manufacturing & Packaging.

Responsibilities:

  • Review and approve change controls and assure proper & timely completion of audits.
  • Write & review SOPs on the operation & maintenance of packaging & manufacturing of solid dosage products.
  • Checking and completing Packaging room or Manufacturing room Start-up & Closing documents.
  • Assure compliance with all Health Canada guidelines and requirements for Non-prescription Drugs, NHP & VHP.
  • Assisting in conducting annual GMP training of employees.
  • Initiation of deviations and investigation.
  • Apply for NDC # for USA OTC Products.
  • Preparation of COAs for Raw Materials, Packaging Materials & Finished Products (OTC).
  • Prepare Release documents.
  • Assure compliance with all Regulatory and Corporate guidelines and requirements.
  • Update and apply NHP & VHP applications.
  • Apply for NDC # for USA OTC Products.
  • Must be able to work independently and submit site license renewal.
  • Conduct & participate in self inspections in accordance with cGMP
  • Release products for NHP & VHP.
  • Update and apply NHP & VHP applications.
  • Reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.
  • Approves raw materials, packaging, and labeling materials.
  • Investigates and records complaints.
  • Reviews Analytical Data.
  • Investigates processes (Out-of-Specification test results and deviations)
  • Reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.
  • Updating all daily, weekly & monthly Maintenance Report.
  • Typical Quality Control functions such as reviewing and auditing batch documents, laboratory test results relating to Finished Product, Stability and Raw Materials.

Requirements:

  • Must have B. Sc (Chemistry or Health Sciences) degree and approved course in Quality Assurance.
  • Minimum of 2 years Quality Assurance experience in the pharmaceutical industry in particular, OTC Drugs.
  • Participation in Health Canada Inspection a definite asset.
  • Knowledge of GMP, U. S. Pharmacopeia.
  • Well versed with Non-prescription Drugs or Natural Health Products Directorate Online System, Common Electronic Submissions Gateway, Providing Regulatory Submissions in Electronic Format to Health Canada and FDA.
  • Supporting documentation related to education and training will be required.
  • Has the appropriate training, experience and technical knowledge in reference to GMP.
  • Excellent written and oral communication skills is a must.
  • Computer proficiency with MS Office programs.

Job Types: Full-time, Permanent

Pay: $60,000.00-$75,000.00 per year

Education:

  • Bachelor's Degree (preferred)

Experience:

  • Quality Assurance experience in pharmaceutical industry: 1 year (preferred)

Language:

  • English (preferred)

Work Location: In person

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