Key Responsibilities:
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* Review and approve validation documentation for Laboratory Information Management Systems (LIMS), lab instruments, and computerized systems to ensure data integrity and system compliance.
* Provide QA oversight during execution of CSV and equipment qualification activities.
* Support the development and maintenance of the Computer System Validation Master Plan and related documentation.
* Ensure validation activities comply with regulatory requirements.
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This role requires a strong understanding of GAMP 5, Annex 11, and 21 CFR Part 11 compliance, excellent documentation, communication, and cross-functional collaboration skills. The ideal candidate has a degree in a scientific or technical discipline and at least 5 years of experience in a GMP-regulated pharmaceutical or biopharmaceutical environment.
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