Computer System Validation Manager

Roles & Responsibilities

CSV Manager (Computer System Validation)

• The Validation Manager role will play a key role in preparing and executing the validation activities here at Qualityze, ensuring alignment with our Customers and Regulatory expectations. The position will entail building strong cross-functional relationships throughout the organization and establish a balanced GAMP5 compliant validation program.
• The Validation analyst will be responsible for conducting Risk Assessment, Impact Assessment, drafting of Installation Qualification (IQ), Functional Requirement Specification (FRS), System Design Document (SDD), Requirement Traceability Matrix (RTM), Operational Qualification (OQ), and executing of IQ, OQ, Process Validation of Qualityze products. Preparing Validation Plan, Validation summary reports for the qualification and validation of systems used internally. Some travel may be required.
• The Validation analyst will be responsible for guiding and providing support to support team for their validation needs.

• Works with Product Owner and Quality Department to prepare and manage computer system validation activities
• Develop computer system validation documents such as Validation Plans, User Requirements, Configuration Specifications, Test Protocols (IQ OQ, PQ), and Validation Summary Reports
• Provides support for customer validation activities and/or UAT
• Creates and maintains the software base validation program framework of Qualityze software solution to meet 21 CFR Part 11 requirements, including Validation Plans and Summaries, testing protocols.
• Maintain documentation throughout the Qualityze Software life cycle to meet future validation needs via change control
• Responsible for reporting status of validation day to day activities to the validation manager
• Applies knowledge of 21 CFR Part 11, EU annex 11, GAMP 5 regulations to create, maintain and improve processes

Skills and Qualifications:

• Knowledge of Agile work practices
• Ability to organize own work based on established priorities
• Effective communication skills: ability to communicate clearly and concisely both verbally and in writing
• Trustworthiness, personal integrity; able to maintain a high degree of confidentiality
• Excellent written and oral communication skills.
• Working knowledge of Microsoft Office products (Outlook, Word, Excel, PowerPoint).

Work Experience and Education Requirements:

• Bachelors degree in Science or Engineering with 10 to 13 years of operational validation experience in pharmaceutical, or biotechnology industry. Masters degree is a plus.
• Demonstrated knowledge of cGMP compliance.

Soft Skills

• Solid work ethic geared towards proving high quality service to clients
• People-oriented -- enjoys interacting with people and working on group projects.
• Detail-oriented -- would rather focus on the details of work than the bigger picture.
• Achievement-oriented -- enjoys taking on challenges, even in the face of possible failure
• Autonomous/Independent -- enjoys working with minimal direction.
• Demonstrated ability in problem solving skills and experience applying these skills to resolve technical problems
• Skilled at prioritizing and organizing work
• Demonstrated experience in writing and reviewing SOPs and protocols for accuracy, traceability, and compliance.

Job Type: Full-time