Skill Area

Key Aspects

Proficiency Levels

Beginner

Intermediate

Advanced

Expert

General CQV Principles

�       Modern process validation and guidance 

�       Validation design and how to reduce variability

�       Able to review a basic protocol

�       Able to review/approve Validation document deliverables.

�       Understands the importance of a well-defined URS.

�       Able to be QEV lead in a small project

�       Able to answer questions and guide others in QEV

�       Participates in process improvement

�       Able to review and approve RTM/SRs

�       Able to be QEV lead in a large project project

�       Trains and mentors others in QEV

�       Leads process improvement initiatives

�       Able to provide Quality oversight on the creation of Validation Plans for complex systems and/or projects

�       Sets overall CQV strategy

�       Recognized as an expert outside of JEB

Facilities and Utilities

�       Oversee Facilities, HVAC and Controlled Environments

�       Pharma Water and WFI

�       Pure Steam, Compressed Air, Medical Gases

�       Understands the principles and GMP requirements

�       Applies the principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating facility fitness-for-use/qualification

�       Guide the Design to Qualification Process for new facilities/utilities or the expansion of existing facilities/utilities

�       Able to establish best practices

Systems and Equipment

�       Equipment, including Lab equipment

�       Understands the principles and GMP requirements

�       Principles, activities, and deliverables that constitute an efficient and acceptable approach to demonstrating equipment fitness-for-use/qualification

�       Able to provide overall strategy for large projects

�       Able to be QEV lead on complex systems and equipment.

�       Able to establish best practices

Computer Systems and Data Integrity

�       Computer lifecycle, including validation

�       Understands the principles and GMP requirements

�       Able to review CSV documents

�       Apply GAMP5 risk based approach

�       Day-to-day quality oversight

�       Able to provide overall strategy for a risk based GAMP5 approach to computer system quality

�       Able to establish best practices

Asset Lifecycle

�       Quality oversight and decision making in the lifecycle asset lifecycle: Plan, acquire, use, maintain, and dispose of assets 

�       Can use CMMS to look up Calibrations, Cal schedules and PM schedules

�       Quality oversight of asset lifecycle decisions

�       Able to provide oversight on Cal/PM frequency

�       Able to assess impact to validated state for corrective WO’s.

�       Able to establish asset lifecycle for new equipment classes

�       Establish risk-based PM for new asset classes

�       Establish asset lifecycle approach

Quality Systems

�       SOP/WI and other GxP Documents

�       Deviation

�       Change Control

�       Able to use the eQMS

�       Deviation reviewer (minor/major)

�       Change Control approver

�       Document author/approver

�       Deviation reviewer (critical)

�       Manage umbrella/Parent changes

�       Able to set strategic direction

Cleaning, Sanitization and Sterilization Validation

�       Evaluate and execute cleaning practices, limit calculations, scientific rationales, and validation documents 

�       Manage the challenges of multi-product facilities in the establishment of limits, determination of validation strategies, and maintaining the validated state

�       Differentiate the requirements for cleaning and sterilization validation when using manual, semi-automatic, and automatic cleaning technologies

�       Review protocols

�       Identify and characterize potential residues including product, processing aids, cleaning agents, and adventitious agents

�       Understand Sterilization principles and requirements 

�       Create, review and approve scientifically sound rationales, validation protocols, and reports

�       Manage and remediate the pitfalls inherent in cleaning after the production of biopharmaceutical and pharmaceutical products

�       Define cleaning/sterilization validation strategy to meet GMP requirements

Quality Risk Management

�       Apply QRM principles according to Q9

�       Participate in a risk assessment

�       Determine appropriate tools

�       Establish risk-based decision-making tools

�       Set risk-based approaches

�       Define risk management program for CQV activities