Manager, Validation Cover Letter

I would like to submit my application for the manager, validation opening. Please accept this letter and the attached resume.

In the previous role, I was responsible for support for Data Integrity projects to identify and ensure the safeguarding of data in compliance with site procedures, regulatory requirements, and corporate policies.

My experience is an excellent fit for the list of requirements in this job:

• Knowledge of commissioning and equipment validation to include, temperature controlled storage and automated production lines, cleaning validation experience
• Application of risk based approach to validation (FMEA, PHA)
• The successful applicant will have excellent communication skills, be a strong influence working at all levels within the Bank
• Collaborative attitude with the willingness to work with global peers toward company and department goals
• Familiar with hardware lab equipment setup and use - oscilloscopes, logic analyzers, function generators
• Experience of executing process validation of Drug Products
• Problem solving and Project Management skills essential
• Extended safety and system assurance of railway products, systems or solution within similar fields

In response to your job posting for manager, validation, I am including this letter and my resume for your review.

In my previous role, I was responsible for quality guidance and assessment to ensure maintenance of, and changes to, validated systems are managed in accordance with current corporate and regulatory requirements;.

Please consider my qualifications and experience:

• Experience in working with teams across geographic boundaries and with matrix organizations
• Experience with multiple disciplines, examples include, not limited to design, verification, or validation in multiple feature areas
• Experience with RTL such as Verilog
• Experience with Software & Scripting Languages C,C++, Python
• Experience working with key customers and customer requirements
• On portable consumer electronics
• Organizer and issue driver
• Engineering education on university level or other relevant background and experience · Experience from product development, verification and validation, mobile applications and underground application are meritorious · Proven management skills · Swedish and English both written and spoken

I would like to submit my application for the manager, validation opening. Please accept this letter and the attached resume.

Previously, I was responsible for ongoing coaching and mentoring to assure that team’s competency remains current with changes in regulatory requirements and industry standards.

Please consider my qualifications and experience:

• Proven coding skills in any combination of Python, C, C++
• Strong understanding of product development life cycle (Hardware, Firmware - Integration testing etc), knowledge on different industrial communication protocols (MODBUS, Ethernet, IEC 61850, BACnet etc)
• Good understanding of product development life cycle (Agile methodology, Integration testing etc)
• Experience with leading/mentoring test projects in an embedded product development environment
• Demonstrated working experience with multi sited teams in different time zones & experienced with knowledge transfer process
• Excellent oral & written communication in English
• Be a team player – should be able to work closely with test leads / peer groups / architects & design teams
• Serve as Subject Matter Expert on controlled documentation (batch records, deviations, investigations, ), regulatory requirements, technical advances in the field of validation, and the latest industry trends

I submit this application to express my sincere interest in the manager, validation position.

Previously, I was responsible for support to resolve outstanding audit and regulatory issues, and to respond to ad hoc senior management and regulatory requests.

Please consider my experience and qualifications for this position:

• Familiarity with FDA and EU regulations for pharmaceuticals and medical devices
• Test management & execution oversight (coordination, communications, collaboration, workload management, scheduling, gate keeping, etc) for our rewards program
• Defect management & prioritization
• Process Improvement identification and suggestions
• Experience in executing formal V&V testing and informal ad-hoc testing
• Knowledge of Quality by Design (QBD) principles and ICH standards for assay validation
• Pharmaceutical Supervisory experience (preferred if supported by work experience)
• Quality-minded, result oriented

I am excited to be applying for the position of manager, validation. Please accept this letter and the attached resume as my interest in this position.

In the previous role, I was responsible for ongoing support for Data Integrity projects to identify and safeguard critical data in compliance with regulatory requirements and corporate policies.

I reviewed the requirements of the job opening and I believe my candidacy is an excellent fit for this position. Some of the key requirements that I have extensive experience with include:

• Of broader testing strategy
• Other products
• Overseeing test plan/test case authoring and execution assignments/progress reporting, and supervising staff
• Experience with qualification, verification and/or validation in a regulated industry
• Experience managing or executing Computer System Validation activities is preferred
• Proficient with computer systems and common terminology
• Experience with automated quality documentation systems
• Provide mentoring and development to staff on an ongoing basis