Specialist, Quality Compliance (Investigations QA)

Full Time
  • Full Time
  • Brampton

Career Connections Canada Inc

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Our  pharmaceutical client in Brampton location is presently looking for a Specialist, Quality Compliance (Investigations QA) to join our QA department.

General Summary:

To provide assistance and support to the Director and Managers of Quality Assurance, regarding compliance activities within the department. This will entail coordination with other departments within the organization.

Principal Duties and Responsibilities :

  • Perform multiple QA of QC duties, which include random verification and review of QC documentation (Analytical Record’s, Phase I OOS, etc.)
  • Monitor and review documents regarding products, raw materials and test methods based on compendial updates
  • Trend, analyze and follow up on OOS Investigations.
  • Create and follow up on all Phase II OOS investigations
  • Work closely with Lab personnel for protocol generation and review for Phase II lab testing (OOS Investigations)
  • Provide support for initiation and investigation of deviations originating from the QC laboratory.
  • Monitor and review documentation for residual solvents, melamine and other compendial or  regulatory submission requirements
  • Provide support for Compendial updates.
  • Review QC specifications for compliance
  • Perform internal/external audits when required.
  • Provide support to QA & Regulatory Affairs Departments as required.
  • Duties may require occasional contact with the Pharmacopoeial & Regulatory bodies.
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all training assignments and maintain personal training records
  • Participate in and/or lead Non Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA’s)
  • Initiate, and follow through with actions required to close Change Controls
  • Participate in Internal, Customer and Regulatory Audits.
  • Other duties as assigned

Knowledge, Skills and Abilities

– University degree in Science – preferably Chemistry
– Knowledge of USP and Regulatory requirements for the pharmaceutical industry
– Knowledge of QC Laboratory Systems, procedures and equipment Systems
– Software skills (Microsoft Word, Excel, PowerPoint, document management systems)
– Minimum of 5 years laboratory experience in the Pharmaceutical industry.
– Organizational ability to maintain a complex and high volume of technical information up to date
– Familiarity with appropriate GMP compliance requirements of pharmaceutical industry
– Excellent interpersonal skills and communication skills (verbal and written)
– Superior level of computer and software skills

• Career Connections Canada Inc. welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process. To request an accommodation, please contact Career Connections Canada Inc

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