Pharmaceutical Quality Assurance Specialist

4 weeks ago

Golden Horseshoe, Canada Pyramid Consulting, Inc Full time

We are seeking a skilled Quality Assurance Associate with a strong background in the Pharmaceutical Sector. This role involves significant responsibilities and offers the opportunity for long-term engagement. Below is an overview of the position's responsibilities and requirements.

Key Responsibilities:

  • Assess reported complaints in collaboration with management to classify defects and evaluate potential risks to marketed products.
  • Oversee investigations by identifying necessary expertise from various departments to create a comprehensive investigational plan.
  • Analyze Batch Production Records and conduct Root Cause Analysis during complaint investigations, utilizing process evaluations and analytical tools to uncover true causes.
  • Inspect returned product samples and facilitate testing procedures.
  • Ensure thorough product retention examinations are conducted to support investigations.
  • Work with 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 for results that inform complaint investigations.
  • Collaborate with Quality Operations and production areas to develop corrective and preventive actions.
  • Identify recurring complaint issues and escalate them for further action as necessary.
  • Provide necessary information to assist in the preparation and submission of Biological Product Deviation Reports to regulatory bodies.
  • Manage the complaint review process, ensuring investigations are concluded within targeted timelines.
  • Log and investigate manufacturing complaints in a timely manner, providing responses to Global Pharmacovigilance.
  • This position typically operates in an office and sample storage environment, requiring focused attention and detailed examination of documentation.

Qualifications and Experience:

  • Proven ability to independently manage investigations in partnership with supporting departments for timely complaint resolution.
  • Experience in managing the categorization and approval of Change Controls in collaboration with relevant departments.
  • Evaluate compliance of master documents against established regulations and guidelines.
  • Lead CAPA projects in collaboration with responsible departments to ensure timely completion.
  • A minimum of a Bachelor’s degree in a relevant scientific field such as Biology, Biochemistry, Microbiology, Immunology, Pharmacology, or Chemistry.
  • At least 5 years of experience in the pharmaceutical industry with a focus on Quality Operations.
  • Strong understanding of GMP regulations and experience interacting with regulatory agencies.
  • Familiarity with various software and databases, including SAP, Trackwise, and MS Office Suite.
  • Strategic thinking and decision-making abilities in a fast-paced environment.
  • Effective verbal and written communication skills across multiple organizational levels; strong presentation skills are essential.
  • Demonstrated ability to write technical reports and work independently.
  • Excellent organizational, interpersonal, and teamwork skills.
  • Strong problem-solving and analytical skills are crucial for this role.

This opportunity is with a leading Pharmaceutical Company that values quality and compliance. We are currently in the process of filling this and similar positions.

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