API Manufacturing Validation Expert
2 weeks ago
Validation & Engineering Group, Inc. (V&EG) stands at the forefront of providing essential services across various sectors, including Pharmaceuticals, Biotechnology, Chemicals, Food, and Medical Devices. Our expertise spans Laboratory Services, Compliance, Engineering, Project Management, Validation, and more.
We are in search of a skilled and dedicated professional who upholds the highest ethical standards for the role of:
- Validation Specialist for API Manufacturing
Key Qualifications:
- A Bachelor's Degree in a relevant field such as Science or Engineering.
- A minimum of 3 years of experience within the pharmaceutical, medical device, or biotechnology sectors.
- Proven experience in the development and scale-up of API processes.
- Familiarity with Quality by Design (QbD) methodologies.
- Experience in validating automated control systems and associated software.
- Proficiency in MS Windows and Microsoft Office Suite.
- Strong understanding of cGxP regulations and their application to ensure compliance.
- Experience in creating and executing Design Documentation (URS, DS), IQ, OQ, PQ protocols, as well as managing deviations and generating reports.
- Exceptional written and verbal communication skills, capable of effectively documenting and presenting validation results.
- A keen attention to detail and a steadfast commitment to quality.
- Knowledge of SDLC, Risk Assessment, Data Integrity, Factory Acceptance Testing (FAT), and Site Acceptance Testing (SAT).
- Strong technical writing abilities and investigative skills.
- Willingness to work extended hours, including potential weekends and holidays.
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API Manufacturing Validation Expert
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