Quality Person In Plant (QPIP): Drug Production

Location: Bloomington, IN
Department: Azzur Chicago, LLC

Job Description

We at Azzur Group are looking for an experienced Quality Person in Plant (QPIP) for Drug Production projects to join our team. 

The Quality Person In Plant (QPIP)for Drug Production will be responsible for the GMP production of COVID 19 Vaccine.

Responsibilities

  • Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure products and processes comply with cGMP requirements.
  • Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CAPA management, change control, and batch documentation review
  • Support regulatory submissions and inspection readiness activities
  • Build relationships and influence external partners to continuously enhance quality culture and business excellence
  • Apply applicable GMP regulations international requirements to all aspects of the position
Required Experience
  • Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline
  • Minimum of 8 years work experience in a regulated pharmaceutical environment
  • Experience in pharmaceutical vaccine manufacturing operations or quality assurance
  • Detailed knowledge of cGMPs related to pharmaceutical vaccine production
  • Strong interpersonal and written/oral communication skills
  • Ability to quickly process complex information and make critical decisions with limited information required
  • Advanced degrees are a plus and may reduce the experience required
Preferred Experience

  • Proficient in applying process excellence tools and methodologies
  • Experience working with external manufacturers
  • Up to 100% travel


Apply Now

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