Prin Qa Validation Scientist, Qa Validation Scientist
Bayer (Oakland/East Bay, California)

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Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.

Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Hematology/Cardiology business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.

POSITION DESCRIPTION
Timely QA review and approval of all protocols and reports referring to
automation and computer systems, process validation,
facilities-equipment-utilities, or Laboratories and Equipment either personally
or through appropriate communication with QA / experts or contractors to ensure
compliance with corporate standards and with regulatory requirements and to
ensure technical and scientific adequacy. Interact with project teams,
manufacturing to provide QA and regulatory expertise and to communicate
requirements for protocols and reports and ensure standardization of validation
procedures. Standardize review and approval workflow for process validation
reports through appropriate forms and documentation. Communicate with other
departments to provide information and training on process validation issues.

1.QA review of validation documents related to automation and computer,
facilities-equipment-utilities, laboratories and equipment, or process
validation systems comprising check for compliance with corporate standards ,
regulatory requirements and technical expertise.
2.Initiate and enforce necessary improvements and corrections; attend team
meetings pertinent to process validation.
3.QA input to Computer Validation Projects for the Site, review of equipment
and utility related protocols, or test method protocols.
4.Define and communicate (e.g. through MRMs) QA acceptance criteria for
validation protocols related to computerized systems, maintain system and
adapt to changing requirements, if necessary bring in expertise to other tasks
within the QA Validation Department (e.g. change control)

POSITION REQUIREMENTS
B.S. in Chemistry, Chemical Engineering, Biochemistry, Computer Sciences or
related field or demonstrated equivalent knowledge with 6+ years of
experience, preferentially working in a GMP environment.

The incumbent must be familiar with regulatory and GMP requirements for
pharmaceutical manufacturing operations. Demonstrated knowledge and experience
in this field is mandatory
The incumbent must be able to communicate this knowledge with peers and
colleagues from other departments therefore a thorough understanding of
equipment, and analytical methods used in GMP environment necessary. Previous
experience in applying and validating analytical test methods, knowledge of
statistics necessary.

Previous supervisory or management experience is desirable.

Strong oral and written communication skills and the ability to work with a
diverse group of personnel of widely varying technical abilities are essential. .