QC Specialist (PHARMA)

March 11 2019
Industries Pharmaceutical, Biotechnology
Categories Pharma, Biotech, Sciences, R&D, Scientific and Regulatory affairs, Quality assurance and control - Validation, Medical and pharmaceutical information, Operations (manufacturing, packaging), Pharmacist, Pharmacovigilance
Varennes, QC

Qualifications:

  • BSc Chemistry (Canadian equivalence recognition)
  • B Pharma (Canadian equivalence recognition)

Requirements:

  • French and English (speak, read and write fluently).
  • Good knowledge of the Canadian Regulations on Drugs and Health Products, Good Manufacturing Practices (GMPs) and Good Pharmacovigilance Practices (GVP).
  • Ability to understand and interpret regulatory language.
  • Ability to work with changing priorities involving multiple and simultaneous projects.
  • Work well in a team, disciplined.
  • Minimum of 2 years of experience in the QC (Pharma).

Responsibilities:

  • Technically qualified QC delegate.
  • Review of manufacturing records and technical documents (certificates of analysis, specifications, analytical methods, stability),
  • Maintain product technical records in good order, easy to access (but controlled)
  • Maintain relations with the analysis laboratories.
  • Assign samples for analysis according to specifications.
  • Release the compliant lots.
  • Reject non-compliant lots.
  • Maintain Standard Operating Procedures.
  • Receive and manage complaints and questions received about the products.
  • Other QA functions to support regulatory obligations.
  • Manage returns and destruction of products.

Location:

  • Mainly from the Varennes office. May be called to work occasionally at offices in Montreal or Laval

Type of employment:

  • Full-time

Certificates and other accreditations required:

Driver's license

Apply now!

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