Computer System Validation Manager

Job Description Overview:

We are looking for a meticulous Computer System Validation Assistant Manager to champion the integrity of our computerized systems at Evertogen Life Sciences. In this pivotal role, you will be instrumental in ensuring our systems meet stringent GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11. Your expertise will drive the development and execution of validation plans, risk assessments, and comprehensive validation documentation across manufacturing, quality control, and utilities. Collaborating closely with cross-functional teams such as QA, IT, and manufacturing, you will oversee system qualification, manage change controls, and ensure data integrity. As a guardian of compliance, you'll prepare for audits, conduct periodic reviews, and foster continuous improvement in our CSV activities. If you're passionate about maintaining the highest standards of data integrity and regulatory adherence within a dynamic pharmaceutical environment, seize this opportunity to make a significant impact on our global operations and contribute to the delivery of safe and effective medicines.

Job Details:

• Industry: Pharmaceutical
• Department: Quality Assurance / IT
• Role: Computer System Validation Assistant Manager
• Location: Hyderabad
• Compensation: 6-8LPA
• Experience: 4-6 years
• Qualification: Bachelor's or Master's degree in Computer Science, Information Technology, or related field

Responsibilities:

CSV Planning and Implementation

• Develop and execute comprehensive Computer System Validation (CSV) plans in compliance with GxP regulations for software used in manufacturing, QC, and utilities.
• Conduct thorough risk assessments and impact analysis for computerized systems used in the manufacturing, quality control, and utilities of oral solid dosage (OSD) products.
• Maintain an updated IT inventory of computerized systems and meticulously review validation documentation, including User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and Validation Master Plans (VMP).
• Create and maintain validation protocols (IQ, OQ, PQ) to ensure systems meet predetermined acceptance criteria.
• Collaborate with cross-functional teams to align validation activities with project timelines and business objectives.

Regulatory Compliance

• Ensure all computerized systems comply with applicable regulatory guidelines, including FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
• Prepare for and actively participate in internal and external audits, providing evidence of system compliance and validation.
• Implement and monitor robust measures to ensure data integrity across all computerized systems, adhering to ALCOA principles.
• Stay abreast of current regulatory requirements and industry best practices related to CSV and data integrity.
• Develop and maintain standard operating procedures (SOPs) related to computer system validation.

System Qualification and Maintenance

• Oversee the qualification of new systems, including laboratory instruments, production equipment, and software applications, using a lifecycle management approach.
• Conduct periodic reviews of validated systems to ensure ongoing compliance, functionality, and performance.
• Manage change controls for updates or modifications to validated systems, ensuring appropriate re-validation activities are performed.
• Troubleshoot and resolve issues related to computerized systems during validation and routine use.
• Ensure proper documentation and tracking of system changes and maintenance activities.

Collaboration and Coordination

• Foster strong cross-functional coordination with QA, IT, OEM, manufacturing, and other departments to ensure seamless validation and compliance of computerized systems.
• Manage relationships with vendors to ensure software and hardware systems meet validation and compliance requirements.
• Provide training and mentorship to team members and end-users on CSV processes and compliance requirements.
• Act as a subject matter expert (SME) for CSV-related inquiries and provide guidance to stakeholders.
• Participate in project meetings and provide updates on validation progress and potential risks.

Risk Management

• Perform comprehensive risk assessments to identify critical system elements and prioritize validation activities.
• Proactively identify and resolve issues related to computerized systems during validation and routine use.
• Identify opportunities for process improvement in CSV activities and implement solutions to enhance efficiency and effectiveness.
• Conduct gap assessments for existing systems to identify compliance gaps and develop remediation plans.
• Maintain a risk register to track identified risks and mitigation strategies.

Documentation and Reporting

• Ensure timely and accurate documentation of all validation activities and maintain comprehensive validation status records.
• Prepare detailed validation reports and summaries for management review and regulatory submissions.
• Analyze trends in system performance and validation data to proactively address potential risks and improve system reliability.
• Maintain a library of validation documentation, including protocols, reports, and SOPs.
• Generate metrics and key performance indicators (KPIs) to track the effectiveness of CSV activities.

General Expectations and Past Experiences:

• Possess a strong understanding of GxP regulations, including FDA 21 CFR Part 11 and EU Annex 11, and their application to computerized systems.
• Demonstrate proven experience in Computer System Validation (CSV) within the pharmaceutical industry, specifically related to OSD manufacturing.
• Exhibit proficiency in validating computerized systems used in OSD manufacturing, including laboratory systems (e.g., HPLC software), ERP systems, and production equipment software.
• Showcase experience with GAMP 5 guidelines and risk-based validation approaches.
• Proficient in creating and reviewing validation documentation, including URS, FRS, VMP, and validation protocols (IQ/OQ/PQ).
• Exhibit strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues related to computerized systems.
• Demonstrate effective communication and team coordination abilities, with experience collaborating with cross-functional teams.