Pharmaceutical Quality Assurance Specialist

4 weeks ago


Golden Horseshoe, Canada Pyramid Consulting, Inc Full time

We are seeking a dedicated Quality Assurance Associate with a solid background in the Pharmaceutical Sector. This role offers a unique opportunity to contribute to quality assurance efforts within a dynamic environment. Below is an overview of the responsibilities associated with this position.

Key Responsibilities:

  • Assess reported complaints in collaboration with management to classify defects and evaluate risks associated with marketed products.
  • Oversee investigations by coordinating with various departments to formulate an effective investigational approach.
  • Analyze Batch Production Records and conduct Root Cause Analysis during complaint investigations, utilizing process evaluations and analytical tools.
  • Inspect returned product samples and facilitate necessary testing.
  • Ensure thorough product retention examinations are conducted to support investigations.
  • Work alongside the Global Pharmacovigilance team to assess potential adverse events as needed.
  • Engage in Focus Factory Support teams for the planning and execution of investigations.
  • Coordinate sample shipments for investigational testing, ensuring compliance with timelines.
  • Develop corrective and preventive actions in partnership with Quality Operations and production teams.
  • Identify recurring complaint issues and escalate them for further action.
  • Assist in the preparation and submission of Biological Product Deviation Reports to regulatory bodies.
  • Manage the complaint review process, ensuring timely closure of investigations.
  • Log and investigate technical complaints and manufacturing issues promptly, providing responses to relevant departments.
  • This position requires a focus on detail and the ability to work in an office/sample storage setting, necessitating high levels of concentration.
Qualifications and Experience:

  • Proven ability to independently manage investigations and collaborate with various departments for timely resolution.
  • Experience in categorizing and approving Change Controls in partnership with responsible departments.
  • Strong understanding of compliance standards for master documents, including Product Specifications and Standard Operating Procedures.
  • Experience managing CAPA projects to ensure timely completion.
  • A Bachelor’s degree in a relevant scientific field such as Biology, Biochemistry, Microbiology, Immunology, Pharmacology, or Chemistry.
  • A minimum of 5 years of experience in the pharmaceutical industry with a focus on Quality Operations.
  • In-depth knowledge of GMP regulations and experience interacting with regulatory agencies.
  • Familiarity with software tools such as SAP, Trackwise, and MS Office Suite.
  • Strategic thinking and decision-making capabilities in a fast-paced environment.
  • Strong verbal and written communication skills, with the ability to present information effectively.
  • Exceptional technical writing skills and the ability to work autonomously.
  • Strong organizational, interpersonal, and teamwork skills.
  • Analytical thinking and problem-solving abilities are essential for this role.

This opportunity is with a prominent Pharmaceutical Company looking to enhance its quality assurance team. We invite qualified candidates to consider this position.



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