Knowledge of software testing in life sciences/Pharmaceutical domain
Must author and execute the software validation test cases - OQ/PQ
Have thorough knowledge on Software Test Lifecycle and Defect Management processes
Good knowledge of cGMP, GAMP, GDP, 21 CFR Part 11 and 21CFR Part 820 guidelines
Review and modify validation documentation including but not limited to: User Requirements Specifications (URS) / Functional Requirement Specification (FRS)
Participate and provide inputs for Functional Risk Assessment
The experience we’re looking to add to our team:
Bachelor’s in Computer Science or Equivalent is required
5-8 years of experience in Pharmaceutical Industry
Strong technical writing to develop validation protocols
Excellent communication skills
Excellent attention to detail, analytical and problem-solving skills
Experience with IQ, OQ and PQ protocols
Knowledge of GMPs
Communicate and collaborate effectively with IT - Business and Quality Teams
Proactive, self-starter and capable of working alone or in a team environment.
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