QA Validation Cover Letter

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

In my previous role, I was responsible for validation representation and subject matter expertise during any investigations related to validation activities at the CMOs.

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

• Become a strong advocate for validation approaches and activities during internal and external audits
• Experience and proficiency with industry standard enterprise system applications (LIMS, SQL, MES, eDMS, ERP, CMMS)
• Professional or academic experience in building and/or testing distributed client/UI and server software using C/C++/C# on Windows Platforms
• Experience as a leader and/or manager
• Understanding of IT systems environments
• Drafts, reviews, and executes protocols and reports related to equipment, facility, method, computer, and process validation
• Extensive knowledge and hands-on experiences of pharmaceutical manufacturing systems processes
• Strong knowledge in validation

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

In my previous role, I was responsible for qA oversight of all GxP computerized system validation activities: conduct validation impact assessments, conduct/lead risk assessments, review and approve all validation related documents.

Please consider my qualifications and experience:

• Used to working in team projects, having cross-functional interaction
• Proven experience and references in a pharmaceutical, biological or biotechnical environment
• Filling or visual inspection equipment validation, Autoclave and Cleaning Validation knowledge would be considered an added value
• Promote, master and ensure quality systems and cGMPs are in place in use
• Act as QMS Subject Matter Expert (SME) and/or Single Point Of Contact (SPOC) on Quality Systems
• Experience with clean or aseptic would be appreciate
• To support the production & technical services teams in the implementation of the validation
• Thorough knowledge of GMP, validation regulations, ICH Q7a Guidelines, Good Documentation Practices (GDP), Good Automation Manufacturing Practice (GAMP) and other applicable regulations

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

In the previous role, I was responsible for qA oversight of all GxP computerized system validation activities for enterprise applications and laboratory instruments across the company: conduct validation impact assessments, conduct/lead risk assessments, review and approve all validation related documents.

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

• Compliance & GxP training
• Familiarity with eDMS and Trackwise preferred
• Requires wearing protective clothing - lab coat, safety glasses, gloves and particulate protection
• Knowledge of validation concepts and current cGMP (21 CFR Parts 210/211, Part 820 & Part 11, ICH)
• Experience in data compilation and review for statistical evaluation
• We would like someone to join our team who isable to multi-task and work in a dynamic environment, customer oriented, and a team player, who has strong communication and problem solving abilities
• A rising Junior or Senior in an undergraduate program majoring in biological or chemical sciences, or engineering disciplines
• Project management experience (classroom experience acceptable)

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

Previously, I was responsible for input and validation guidance to project activities, attends related meetings for project / area / cross-site efforts.

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:

• Supporting new buildings/systems (classroom project experience acceptable)
• Certification in Six Sigma and/or a certification in project management (PMP)
• Hands-on experience and understanding of major Lab Systems (like NuGenesis, Empower, LabWare, Nucleus ) supporting pharmaceutical QC/QA/manufacturing operations
• Good understanding of IT related to computerized systems development, implementation & Operations
• Experience in leading conversation during regulatory inspections
• Extensive experience of Protocol & Report review (IQ, OQ, PQ, Analytical method validation- QC, IPC Methods) along with related documents
• Positive, open-minded and proactive, adding energy to the team by taking responsibility
• Excellent and effective communication skills, being used to working with different cultures

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

In the previous role, I was responsible for oversight, and planning of Validation activities, Site Validation Master Plan, including validation status matrix for key equipment, processes, and products for site.

Please consider my qualifications and experience:

• Previous Quality Assurance and/or Validation management experience
• Bachelor in Sciences (Engineering or Life Sciences)
• Strong experience in in Commissioning and Qualification of Equipment and/or Facility and/or Utility, and in process and cleaning validation
• Drafts, reviews, and executes protocols and reports related to equipment, facility, and computer validation
• Strong software skill such as Python, Visual Basic, C is an added advantage
• Strong hands on development experience in Continuous Integration ,Automatic Testing
• Very good understanding of system architecture, System Debug
• Very strong understanding in Hands-on experience with platform debug and validation methodologies