Quality Person In Plant (QPIP): Drug Substance

Location: Baltimore, MD
Department: Azzur Washington DC, LLC

Job Description

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

The Quality Person In Plant (QPIP) will be responsible for Drug Substance related projects and GMP production of COVID 19 Vaccine.

Key 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.
  • ii. Following successful tech transfer, support day-to-day quality oversight or production activities in the manufacturing plant, including identification of risks, deviation and CPA 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 cGMP regulations and other FDA and 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 working in an FDA regulated environment
  • Extensive experience with biologics manufacturing operations or quality assurance
  • Extensive experience in aseptic processing
  • Detailed knowledge of cGMPs related to pharmaceutical 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
  • Experience in vaccines production
  • Proficient in applying process excellence tools and methodologies
  • Experience working with external manufacturers

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