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