Job Description
- Develop and execute commissioning and qualification plans for systems and equipment, including IQ, OQ, and PQ protocols.
- Perform hands-on testing and validation; develop and implement validation strategies for processes, equipment, and software.
- Conduct risk assessments, manage validation documentation, and execute process, cleaning, and computer system validations.
- Ensure compliance with FDA, EMA, and cGMP regulations; stay updated on industry standards and prepare for regulatory audits.
- Maintain and review validation documentation; prepare and present validation reports and results.
- Identify and resolve validation-related issues, conduct root cause analysis, and implement corrective actions.
- Collaborate with engineering, QA, manufacturing, and IT teams; provide training on validation and compliance.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field and 1-3 years of experience in CQV within pharmaceutical industry.
- Strong knowledge of GMP, FDA regulations, and industry standards; proficiency in validation, problem-solving, and communication skills.
