Quality Person in Plant (QPIP): Packaging

Location: Allentown, PA
Department: Azzur IT, LLC

Job Description

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

The Quality Person In Plant (QPIP) will be responsible for supporting tech transfer and GMP production of COVID 19 Vaccine.

Key Responsibilities
a. 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.
b. Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CPA management, change control, and batch documentation review.
c. Support regulatory submissions and inspection readiness activities
d. Build relationships and influence external partners to continuously enhance quality culture and business excellence.
e. Apply cGMP regulations and other FDA and international requirements to all aspects of the position.

Required Experience/Knowledge
a. Bachelor’s Degree with a concentration in engineering, science, or an equivalent technical discipline.
b. Minimum of 8 years working in an FDA regulated environment.
c. Extensive experience with biologics manufacturing operations or quality assurance.
d. Extensive experience in aseptic processing.
e. Detailed knowledge of cGMPs related to pharmaceutical production.
f. Strong interpersonal and written/oral communication skills.
g. Ability to quickly process complex information and make critical decisions with limited information required.
h. Advanced degrees are a plus and may reduce the experience required.
I. Experience in vaccines production

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