Position Summary
The Validation Manager is responsible for the Validation Master Plan (VMP) and managing qualifications and re-qualifications. This includes the review and approval of validation protocols, reports, and related documentation such as: User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of process equipment, facility equipment and utility systems. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.
Key Responsibilities
- Coordinate and maintaincritical validation responsibilities such as planning, scheduling, identifying resource requirements (people and equipment), coordinating with other departments, and ensuring compliance with applicable VMPs.
- Provides input to, reviews and approves User Requirements Specifications (URS).
- Review and approves protocols includingCycle Development Protocols,Investigational/Engineering Study Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
- Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.
- Researches equipment and processes, and establishes parameters and methods to test equipment to meet validation requirements.
- Ensures an effective coordination of the execution of qualifications and all aspects of the validation projectwith other departments, including but not limited to: Operations, Engineering, Quality Controland Quality Assurance.
- Ensures that the execution of protocols and all related documentation is in compliance with currentGood Documentation Practices.
- Ensures equipment used for qualification purposes is properly maintained and calibrated.
- Supports and participates in change controlprocess for criticalsystem/equipment updates and repairs performedthrough the Work Order control mechanisms. Fully understands the requirements of each change control procedure.
- Assists in equipment troubleshooting and the use of problem solving techniques to resolve issues that could impact the validated state of equipment.
- Performs other dutiesas assigned and required.
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations.Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
Requirements
- 4-6 years of validation experience in the pharmaceutical or other GMP-regulated industry
- Experience with aseptic processes is preferred
- Bachelor’s Degree in engineering, science or another discipline with equivalent work experience
- Knowledge of Microsoft Project, Trackwise, AMMS preferred
- Demonstrated ability to communicate effectively with others
Physical Requirements of the Role
Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 25 lbs. Standing, walking, bending over and repetitive use of legs are done occasionally.
Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may affect the safety or quality of a drug product shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.
