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V Check the simulated data to ensure that required test data have been
produced.
V Obtain expected results from the acceptance test plan and review them
for completeness.
V Calculate any missing expected results.
V Be certain that the introduction of new load modules is according to test
configuration management procedures. When a new, corrected load
module is received, first rerun tests that previously failed because of
software errors. If these tests succeed, proceed with regression testing.
V Analyze and report test results. Evaluate test results as soon as possible
after execution. Wherever possible, use automated tools in the analysis
process. Record analysis procedures and keep all relevant materials.
Remember that records and reports should give complete accounts of
the procedures followed. If a test cannot be evaluated, note the fact and
report the reasons for it.
V Compare all test results with expected results and note that all defects
are documented, regardless of how minor they appear or whether they
will be corrected.
mhe Director QA must be a strong advocate of compliance,
a good trainer and leader, and an accomplished manager of
technical resources with a proven record in building and
motivating successful Quality Assurance efforts. An in-depth
knowledge of regulatory requirements and their interpretation
such as current Good Manufacturing Practices, Good
Laboratory Practices, Stability Guidelines, validation, cleaning
validation, facilities, equipment and other requirements as
they relate to the production of pharmaceutical products, is
required. Must have expert knowledge of development,
production and control systems, have training, education and
experience in Quality Assurance. Must possess sound
reasoning ability, analytical, and creative skills to investigate
systems problems in order to recommend and implement
solutions.
V Plan, organize, direct, control and evaluate the activities and operations
related to quality control and assurance
V Develop and implement policies, standards and procedures for the
engineering and technical work performed in the department, service,
laboratory or firm
V Consult and negotiate with clients to prepare specifications, explain proposals
and present engineering reports and findings
V Assign, co-ordinate and review the technical work of the department or
project teams
V Recruit personnel and oversee development and maintenance of staff
competence in required areas
V May participate directly in the design, development and inspection of
technical projects or in the engineering work of the department.
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