Lead Quality Systems Specialist (Quality Assurance)
Company: Catalent Pharma Solutions
Location: Baltimore
Posted on: March 21, 2023
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Job Description:
The -Lead Quality Systems Specialist (Quality Assurance) is
responsible for supporting Quality Systems, including hosting
client/regulatory inspections, conducting for cause and internal
audits as assigned, coordinating audit logistic planning/prep,
inspection readiness training, drafting audit reports and
responses, conducting inspection readiness/compliance training,
investigation/deviation management, CAPA tracking, and change
control. This position will facilitate the compiling, trending and
reporting key quality metrics for management, and other quality
system functions, as needed. Continuously monitor systems and
procedures to ensure compliance with applicable regulatory and
industry standards, quality improvements, and efficiency for phase
appropriate GMP manufacture of biological products. Exercise
judgment within defined Quality Assurance and Manufacturing
procedures to determine appropriate action for resolution of
manufacturing issues.Catalent hires people with a passion to make a
difference to the health of millions of people globally. Your
expertise, coupled with Catalent's advanced technologies and
collaboration with thousands of innovative pharmaceutical, biotech
and healthcare companies, will help bring life-enhancing products
to the people you know and love. -Your talents, ideas and passion
are essential to our mission; to develop, manufacture and supply
products that help people live better, healthier lives. Interested
in learning more about life at Catalent? -The Role:--- - -
-Supports administration for CAPA, Investigation, and Deviation
systems. Includes, facilitating the closure of items with the
applicable departments to ensure completion and timely
resolution.--- - - -Responsible for tracking and trending aspects
of the Quality System and provide reports to management identifying
risks and trends on a routine basis.--- - - -Performs CAPA
effectiveness evaluation based on quantitative and qualitative
measurements.--- - - -Administer the Change Control process for the
site and conduct effectiveness verification for changes
implemented; Maintains tracking mechanisms to support various
Quality Systems elements and ensures visibility throughout the
organization--- - - -Continuously monitor and review systems and
procedures for adherence to regulatory compliance, quality
improvements, efficiency and industry best practices. Provide
compliance support and expertise for QA department; Participate in
compliance remediation plans and implementation.--- - - -Assists
with the generation and/or revision of GMP documentation such as
standard operating procedures.--- - - -Coordinates on-site client
audits, preparation of audit materials, and ensure timely response
and resolution to client observations; Assists with performing
internal audits.--- - - -Works cross-functionally with departments
to review and improve upon Quality System metrics; Participate in
site quality and process improvement initiatives. Represent QA on
site project teams.--- - - -Other duties as assigned -The
Candidate:--- - - -Minimum of a B.S. in a Life Sciences
discipline--- - - -6 years' experience in Quality/Compliance within
the biologic, biopharmaceutical, or regulated pharmaceutical
industry and direct experience leading a QMS subsystems--- - -
-Experience within the biologic, pharmaceutical or medical device
industry performing direct hands-on work in a Quality Assurance
function ---- - - -Have the knowledge, and ability to apply basic
scientific and regulatory principles to improve quality systems---
- - -ASQ (American Society of Quality) or RAPS (Regulatory Affairs
Professionals Society) highly desirable--- - - -Exposure to Lean
Operational Excellence highly desirableWhy you should join
Catalent:
Keywords: Catalent Pharma Solutions, Baltimore , Lead Quality Systems Specialist (Quality Assurance), Other , Baltimore, Maryland
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