Validation Cover Letter

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

In my previous role, I was responsible for technical support to Development and QC groups on cGMP implementation and validation of manufacturing equipment for new processes.

Please consider my experience and qualifications for this position:

• Maintain knowledge relating to validation activities with an emphasis in cGMP
• Relevant quality experience, not necessarily within a quality department
• Experience with process (CCIT, Capping, leak testing, Filters)
• Need to have knowledge in the key activities related to process ( CCIT, Capping, leak testing, Filters, E&L/ chemical compatibility)
• Strong computer, scientific, technical writing, and organizational skills
• Thorough knowledge Mass Spec instrumentation and the interaction of application software with computer operating systems and network integration
• Understanding of lab instrumentation and/or quality related software tools
• Demonstrated understanding of process verification and validation methodologies, manufacturing / production process control methodologies, in an in vitro diagnostic industry or other regulated environment

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

In the previous role, I was responsible for or arrange for development of complete verification documentation in accordance with company Quality Standards and cGMP requirements for assigned work stream.

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

• Good knowledge of site safety regulations
• Comprehensive knowledge of the validation lifecycle and how it can be applied efficiently whilst remaining compliant
• Comprehensive knowledge of the regulatory requirements for areas of expertise
• Awareness of how the impact of technical changes can affect the quality of the product, any impact to the overall order fulfilment process and suggest how this can be avoided / minimized
• Experience and knowledge of quality, safety and environmental regulatory requirements
• Working knowledge of relevant Site systems, MERPS, Novamanage / CDMS, MaCC, LabC21
• Participation and/or completion in Testing certification programs (Six Sigma, CQSA (Certified Software Quality Analyst), CSTE (Certified Software Tester) or CSTP (Certified Software Test Professional))
• Has a strong working knowledge of the QA review and testing process, designing test scenarios and test scripts, including understanding a various testing techniques

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

Previously, I was responsible for technical direction for platform, SoC and component design activities.

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:

• Preferentially experience of quality system requirements to worldwide markets, especially Europe and USA (ISO 9001, ISO 13485, US FDA QSR)
• Proficiency with PCs and software such as Access
• Quantitative analysis skillsSearch Jobs US
• Working knowledge of Software Development Life Cycle (SDLC), ITIL foundation, change management, and other IT processes
• Strong project management, problem solving, and process improvement skills
• Expertise with analytical methods (HPLC, CGE, chromogenic methods, biochemical tests)
• Knowledge of analytical method validation and critical reagent qualification
• Statistical knowledge and experience with data analysis

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

In the previous role, I was responsible for daily guidance and direction for manufacturing, packaging, engineering, and warehouse activities to assure cGMP requirements are met.

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

• Knowledge of regulatory requirements concerning analytical test methods (EP/USP)
• Fluency in German and English (sufficient for international teleconference calls)
• Knowledge of Domestic and International Regulations and Industry Standards
• Demonstrates team skills
• EMC Testing background
• Experience in the interpretation and application of FDA requirements and cGMP are necessary
• Working knowledge of 21 CFR Part 11 regulations applied to computer systems
• Basic understanding of statistics preferred

Please consider me for the validation opportunity. I am including my resume that lists my qualifications and experience.

Previously, I was responsible for technical support to help develop and execute project plans and obtain and analyze relevant data and prepare appropriate reports as per cGMP requirements.

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

• Strong understanding of electrical circuit analysis, design, and test fundamentals
• Automation of Analog Characterization Setups using Labview and Test Stand
• Bring up of Silicon & Analog Validation Platforms like Analog Board for new ASIC/SoC design
• Highly motivated, energetic individuals to take up bench characterization challenges on stand-alone /automated bench setup
• Prepare and implement FAT, IQ, OQ & PQ Protocols
• Organize and coordinate FAT, IQ, OQ, PQ activities with the different involved departments and in such a way that all of them concur to the timeframes committed with the project leader
• Analyze, interpret, document and report the testing results
• Collect and approve results of validation activities, assure issuance of reports and allow release of impacted product in accordance to internal procedures