Executive / senior industry position
The software quality assurance engineer is responsible for assuring that computerized systems associated with the manufacture of pharmaceutical product is validated in accordance with regional and local procedures and cGMP regulation and guidelines. Job assignments are to be completed without a considerable amount of supervision or coaching.
1. Maintain a list of all computerized systems that are used in the manufacture of pharmaceutical product.
2. Assure 21 CFR Part 11 pre- and post-assessments are performed on all systems.
3. Assure that computerized systems are released to production in accordance with regional and local procedures.
4. Review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies.
5. Assure that computerized systems are in the requalification program and are part of the program for security access review.
6. Provide guidance to project teams on the deliverables required as part of the validation package.
7. Assure that all computerized systems are compliant with regulatory guidance's, including 21 CFR Part 11 and Data Integrity.
Assume responsibility for the implementation and validation of computerized systems associated with the manufacture of pharmaceutical product.
Five or more years of computerized systems/SQA experience is required. Strong organizational, analytical, computer, writing, and communication skills. Project management is a plus. Knowledge of aseptic manufacturing experience is highly desired. Excellent logical/mechanical aptitude is desired. Knowledge of cGMP regulations and latest validation guidelines. Able to handle multiple priorities in a fast-paced environment. Able to
work extended/flex hours around the manufacturing schedule.
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