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http://biotech.fyicenter.com/jobs/99895897_Clinical_Research_Associate__.html
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Date: 13-Sep-2007
Clinical Research Associate
Requirements:
M.Sc /B.Sc in Biological Sciences, Chemistry, Pharmacy, or related
science discipline.
5 years of experience in Quality Assurance in a GMP Manufacturing
Facility
Experience in parenteral manufacturing and quality, a plus.
In-depth knowledge of GMP regulations, ICH guidelines, and emerging
industry standards. Ability to interpret and apply government
regulations and guidelines to the operations of a site.
Must have knowledge in multiple areas, including do***ent control,
change control, GMP training, batch record/analytical review and
product disposition, complaints handling.
Proven strong problem solving ability with attention to root cause
identification.
Knowledge of quality engineering principles, theories, concepts and
techniques in a pharmaceutical environment, including process
validation, cleaning validation, equipment qualification, facilities
and utilities qualification, etc.
Ability to deal effectively with all levels within the organization as
well as with external parties, including regulatory authorities.
Must be able to present and defend GMP do***entation associated with
quality practices.
Good interpersonal and verbal/written communication skills.
Job Responsibilities and Accountability:
Provide expertise in interpreting and applying regulatory guidelines
to ensure that pharmaceutical manufacturing operations, facilities and
do***entation adhere to regulatory requirements, company procedures,
and are consistent with industry standards.
Enforce and evaluate/reevaluate specifications and control limits from
a technical and compliance perspective.
Provide input in the development of process specifications, batch
records and other quality related manufacturing do***ents.
Review and approve all GMP do***ents including, quality control data,
study/validation protocols, validation protocol deviations, failure/
discrepancy investigations, stability re****ts, method validation
re****ts and validation re****ts (includes IQ, OQ and PQ)
Develop and maintain internal company SOP's and organize the annual/
periodic SOP reviews.
Establish and maintain, in conjunction with manufacturing and quality
control, safety strategies and ensure that the appropriate cGMP
guidelines are met, implemented and maintained
Develop and implement program for quality self-inspections and review
of manufacturing, testing and stability programs.
Provide technical sup****t and quality assurance oversight to third-
party providers (Contract manufacturing organizations, clinical
Supplies manufacturing, contract Testing Laboratories), to meet GMP,
ICH guidelines and the requirements of applicable Health Authorities.
Lead compliance audits of third party suppliers, manufacturers, and
distributors. Provide professional expertise and strong leader****p in
proactively identifying issues/risks at facility, contract
manufacturers, contract testing laboratories, and partners who supply/
distribute clinical and commercial products.
Release of Drug Substance, Intermediates and Clinical Drug Products.
Maintain site Deviation, Investigation and CAPA, Batch Disposition and
Complaint Quality systems.
Conduct training program of personnel associated with cGMP activities
at the Site.
Notify Senior Management of any potential quality issues associated
with the manufacture or distribution of products, both internally
manufactured and contract manufactured products.
Thank you,
BioTech FYI Center
http://biotech.fyicenter.com/
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