Responsibilities:
Conduct validation activities for laboratory and manufacturing systems, ensuring compliance with regulatory requirements and company standards.
Perform gap analysis of existing systems to identify areas for improvement and ensure alignment with regulatory standards.
Lead retrospective validation efforts to ensure legacy systems meet current regulatory expectations and industry best practices.
Collaborate with cross-functional teams including Quality Assurance, IT, and Operations to develop validation protocols, test scripts, and validation plans.
Execute validation protocols including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for computerized systems.
Document validation activities, findings, and deviations according to standard operating procedures and regulatory guidelines.
Provide expertise and guidance on computerized system validation principles, methodologies, and best practices.
Participate in regulatory inspections and audits, providing support and documentation as required.
Stay current with regulatory requirements and industry trends related to computer system validation.
Requirements:
Bachelor's degree in Computer Science, Engineering, Pharmaceutical Sciences, or related field.
2 to 5 years of experience in computer system validation within the pharmaceutical industry.
Solid understanding of regulatory requirements including FDA regulations (21 CFR Part 11, Annex 11) and GAMP 5 guidelines.
Experience with lab and manufacturing systems validation is highly preferred.
Proficiency in conducting gap analysis and retrospective validation activities.
Excellent analytical and problem-solving skills with keen attention to detail.
Ability to effectively communicate and collaborate with cross-functional teams.
Experience in writing validation protocols, test scripts, and validation plans.
Familiarity with document management systems and electronic record keeping.
Willing to travel and work at client location