<\/span><\/span><\/p>- Develop and review validation plans, protocols (IQ, OQ, PQ), and reports for computerized systems.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Perform risk assessments and impact analysis related to system validation.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Ensure compliance with regulatory guidelines such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Collaborate with IT, Quality Assurance, and Manufacturing teams to support system qualification and validation activities.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Manage change control and deviation investigations related to validated systems.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Support audits and inspections by regulatory authorities.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Maintain validation documentation and ensure traceability throughout the system lifecycle.<\/span><\/span><\/span>
<\/span><\/span><\/li><\/ul><\/div><\/span>
Requirements<\/h3>
<\/span><\/span><\/p>- Bachelor’s degree in Pharmacy, Life Sciences, Engineering, Computer Science, or related field.<\/span><\/span><\/span>
<\/span><\/span><\/li>- 5 -8 years of experience in CSV within pharmaceutical manufacturing or related regulated industries.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Strong knowledge of GxP regulations, 21 CFR Part 11, Annex 11, and GAMP 5 guidelines.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Experience with validation of PLC SCADA, MES, or other pharma manufacturing Automation systems.<\/span><\/span><\/span>
<\/span><\/span><\/li>- Excellent documentation and communication skills.<\/span><\/span><\/span>
<\/span><\/span><\/li>Ability to work independently and in cross -functional teams.<\/span>
<\/span><\/span><\/div><\/li><\/ul>
<\/div><\/span>
