QA Validation Consultant

4/2018 – 1/2023

Validation consultant on remediation project to align
client's quality system with current regulatory standards
ISO 13485, 21 CFR Part 820, and EU MDR 2017/745.

Conducted risk assessments and gap analysis concerning
validation status of processes, equipment, injection
molding components, adhesive bonding (gluing and curing
process), welding of polycarbonate components, multiple
packaging processes, tube cutting, ultrasonic welding, and
design test method.

Created and updated SOPs, MVPs, dFMEA, and pFMEA to
document the current validation status of equipment,
processes, etc., and to prioritize future validation
activities.
•
Worked with consultants, internal employees, and with
external vendors on the remediation of the quality system
as a pre-requisite for execution of planned validation
activities.

Planning, documentation, and execution of process
validation activities (IQ, OQ, PQ, and TMV).
•
Generated and executed of Design test method validation
- Validation Assessment, Risk Assessment, Traceability
Matrix, Feasibility Plan and report, Validation Plan and
report, M-PQ and IM components qualifications within the
remediation projects.

Executed and supported CAPA investigations to address
findings from internal and regulatory body audits including
FDA, particularly with validations.

Initiated continuous improvement efforts by analyzing
process data, identifying areas for optimization, and
implementing innovative solutions to enhance
productivity, quality, and safety.

Prozessvalidierung

12/2016 – 12/2017

Integrated with cross-functional teams from
manufacturing, engineering, Quality, Process
Development, Engineering, R&D and supported validation
requirements on a wide range of projects including
external vendor, and subcontractor representatives.
•
Planning, documentation, and execution of equipment and
system qualifications URS, FDS, DQ, FAT, SAT, and
associated trace matrices across a range of molding,
automated equipment, and computer systems.
•
Conducted Process Development, DOE, and validation
sampling and inspection plans based on Risk Assessment.
•
Drafted and executed IQ, Process Development, OQ, and
PQ on new/revised processes.
•
Performed validation testing, analyzed data, and
generated comprehensive reports to support decisionmaking.
•
Created and controlled pFMEA, Control Plans, and Risk
Management documentation through the product life
cycle.
•
Provided training and technical support to operators,
maintenance personnel, and other members on process
control systems and equipment usage, troubleshooting,
and best practices.

• Participated in regulatory audits and inspections.

Prozessvalidierung

11/2015 – 11/2017

Developed validation and qualification protocols and
tracked executions of protocols in support of project
timelines.
•
Developed and executed validations through all phases i.e.
FAT, SAT, IQ, OQ, PQ, and Validation reports.
•
Reviewed and approved validation documentation to
ensure that site validation requirements were met.
•
Reviewed and analyzed protocol data to determine if
requirements were met. Resolves discrepancies and
deviations during protocol execution.
•
Prepared and executed validation protocols, assisted with
engineering and external vendors regarding equipment
User Requirements Specifications (URSs), DQ
•
Maintained quality evaluation and control plans and
protocols for processing materials into finished products.
•
Analyzed inspection and testing processes, mechanisms,
and equipment.
•
Analyzed and computed statistical techniques, i.e. Process
Capability (Minitab) & Gauge RR, etc.
•
Developed and maintained validation and qualification
system-level documents including master validation plans,
policies, and procedures.
•
Supported with completion of corrective actions (CAPA) in
accordance with relevant ISO requirements (ISO 9001, ISO
13485, and ISO 14644), utilizing advanced problem-solving
methods, and ensuring documentation was complete and
compliant with requirements.
•
Assisted in process validations/qualifications in
accordance with customer requirements.
•
Assisted with internal supplier third-party and FDA quality
audits

Prozessvalidierung