Senior Quality Assurance Specialist Cover Letter

Please consider me for the senior quality assurance specialist opportunity. I am including my resume that lists my qualifications and experience.

In the previous role, I was responsible for guidance and support for our UL Compliance to Performance CSV framework based on FDA 21 CFR parts 11, 58, 211, 820, GAMP 5 and other regulatory requirements.

Please consider my qualifications and experience:

• Knowledge of Quality Systems tools such as FMEA and Root Cause Analysis
• Able to identify solutions not just problems
• Able to appreciate client view point
• Participate in products release business
• BS in Chemistry/Pharmaceutical or equivalent
• Familiar with GMP/ISO documentation management and training
• Familiar with Quality Electronic systems such as SAP, trackwise
• New project experience is preferred

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

Previously, I was responsible for recommendations to Testing Facility and Quality Management for improvements in auditing of Quality Systems based on extensive knowledge and understanding of current regulatory inspection guidance and internal trends.

Please consider my qualifications and experience:

• Hands-on experience or understanding of shop-floor systems supporting pharmaceutical manufacturing operations
• Experience managing a computer systems validation function and understanding of the key requirements of the FDA GxP regulations
• Demonstrated experience working in a regulated environment including a thorough understanding of 21CFR Part 11 and Good Automated Manufacturing Practices (GAMP)
• Understanding of information systems, business processes, key drivers and measures of success for the relevant business
• Experience providing application support in a fast paced, high growth business environment
• Excellent organizational, planning, interpersonal and customer service skills and delivery focused orientation in areas such as teamwork, negotiation and collaboration
• Knowledge of Federal Consumer Laws and Regulations
• Experience with vendor management, incoming quality, raw materials, and quality systems management

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

In my previous role, I was responsible for support of quality systems/programs including but not limited to document management, deviation, CAPA, change control, inspection management, audits, and training.

Please consider my qualifications and experience:

• Quality assurance experience, including but not limited to packaging technologies, packaging materials, components, art-work, design development, technology transfer, validation, distribution activities, shipping lane verification, temperature excursions resolutions
• Previous experience managing third party, CMO and distribution partners is preferred
• Knowledge of cGMP, ICH and all applicable global regulations is preferred
• Experience in Document Control and CAPA systems preferred
• Should possess strong interpersonal and coordination skills
• Knowledge of TRID (Reg Z) and HMDA (Reg C) guidelines
• Demonstrate accuracy, thoroughness and extreme attention to detail
• Manages time well

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

In my previous role, I was responsible for subject matter expertise to HVT regulatory personnel on regulatory requirements primarily for US and Europe, but also international.

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

• Familiarization with software and software/hardware development process within a regulated industry
• Conducts QA audits, generates audit reports, communicates results to the relevant QA management and relevant stakeholders, and interacts with applicable stakeholders to ensure corrective and preventative actions are taken to address QA findings
• Design and actively participate in special assignments on various project teams and work streams
• Hands-on experience working in COMET SAP (e.g., creation and maintenance of master data / objects – not expense reporting)
• Proven project management proficiency and driving process improvements
• Senior Managers across BMO Business Continuity Coordinators
• US Business Continuity Management Quality Assurance Team
• Creation or operations experience in a wide variety of change control systems is preferred

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

In my previous role, I was responsible for appropriate QA consultation to ACM personnel.Consultation must meet current regulatory requirements and be appropriate for the business.

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

• Where applicable, ensure adherence to MMD Quality Manual and provide feedback to MMD Quality Manual Chapter owners
• Health Authority (HA) interactions and notifications regarding Quality and Supply issues
• Information and interaction with local business and regional Quality Management
• Ensure Quality perspective is brought into local business initiatives with Quality impact
• Local coordination and execution of recalls
• Primary country contact for MMD Quality
• Primary country contact for HA issues pertaining to Quality and Supply issues
• Moroccan’s nacionality