Validation Specialist Cover Letter

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

In my previous role, I was responsible for leadership and SME knowledge in the area of validation (process, cleaning and Utilities) and across all levels at the site, ensuring compliance with current industry regulations, guidelines and trends.

Please consider my experience and qualifications for this position:

• A working knowledge of utilities and general production systems used in non-sterile pharmaceutical manufacturing
• Advanced knowledge in supply chain management, processes, biopharmaceuticals technologies
• Knowledge of regulatory
• Knowledge of GKK Bio vaccines
• Good Knowledge of culture and purification processes
• Good knowledge of QC technologies
• Good knowledge of cleaning validation aspect
• Quality background and knowledge of GAMP5 requirements

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

Previously, I was responsible for quality oversight to site facilities, utilities, instruments and equipment qualification and process, packaging, computer systems, and cleaning validation.

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:

• Considered globally as a key knowledge holder for specific markets or applications
• Contributes to Sales and Marketing product development
• Proven experience in project management and complex sales
• Fluent in English and a second European language would be beneficial
• Knowledge of cGxP
• Knowledge of GAMP5
• Knowledge of validation practices
• PC skills including MS Office and Outlook

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

In my previous role, I was responsible for subject matter expertise in carrying our Computer System Validation on GxP systems to ensure compliance with all applicable regulations including FDA's GLP and GMP/Part 11 and EU Annex 11 and industry guidelines such as ISPE GAMP5, MHRA’s GxP Integrity Guidelines, and GDPR.

Please consider my qualifications and experience:

• Logical, detail oriented and highly organized
• Know how in analytical methods such as ELISA, spectroscopy, HPLC, PCR and microbiological tests
• Technical or natural sciences background (biotechnology, biochemistry, chemistry or similar)
• Experience in a QC lab environment
• Knowledge about analytical method validation and critical reagent qualification
• Experience in problem solving (facilitation and application of tools)
• Basic statistical knowledge and experience with data analysis
• Basic knowledge about regulatory requirements concerning analytical test methods and licenses

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

Previously, I was responsible for quality guidance on GMP regulatory requirements (including 21CFR Parts 210, 211, 820, Part 11).

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

• Strategical and analytical thinking
• Have Troubleshooting and analytical mind-set
• Able to be on call for regional teams as needed
• Minimum of Bachelor of Science or equivalent
• Experience in Assay and Equipment validation to ENFSI/SWGDAM guidelines and ISO 17025
• Technical expertise in defined specialist market with broad knowledge of Human ID & Forensic Solutions
• Drive adoption of new technologies through key opinion leaders, seminars, national conferences, references, demonstrations and other as applicable
• Validate successful selling channels, processes and opportunities

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

In the previous role, I was responsible for lead QA important support for the validation (process and cleaning) activities, including approval of the validation protocols and reports and other documentation.

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:

• Basic understanding of home networking such as
• Working knowledge of utilities, cleaning validation concepts, and general production systems used in pharmaceutical manufacturing considered an asset
• Experience qualifying equipment such as incubators and autoclaves considered an asset
• Experience in Solid Dose Manufacturing and Packaging Equipment considered an asset
• Working knowledge of statistics and analysis tools
• A thorough understanding of computer systems validation guidelines issued by regulatory agencies including the FDA and experience with computer systems validations in compliance with FDA 21 CFR Part 11
• Experience managing IT and validation staff
• Experience in supporting an enterprise-wide LIMS or other data management system