Dear Hiring Manager,
I am writing to express my interest in the job opening within your esteemed organization. As an accomplished professional with over 13 years of experience in the pharmaceutical laboratory environment, I have built a strong foundation in analytical testing, validation, and Quality Management Systems (QMS). My proven ability to manage complex projects, ensure regulatory compliance, and execute computer system validations (CSV) positions me as a strong candidate for this role. I am particularly adept at ensuring adherence to cGMP, GLP and EHSS policies, with substantial experience in managing quality control processes and leading teams through audits, including successful US-FDA and EU-GMP, ANVISA inspections.
In my current role as Deputy Manager in the Quality Control Department at MAIVA Pharma Private Limited, I have consistently ensured that laboratory operations comply with EHSS, cGMP, data integrity, and IT policies. I have successfully managed the preparation and review of protocols and reports, performed method validation for a diverse range of pharmaceutical products, and conducted in-depth investigations into Out of Specification (OOS) results and incidents using TrackWise. My ability to develop and maintain Standard Operating Procedures (SOPs), coupled with my expertise in Computer System Validation (CSV) following GAMP5 and 21 CFR Part 11, and my experience with JIRA software for comprehensive project tracking and management, has consistently ensured regulatory compliance and process optimization."
Throughout my career, I have gained extensive hands-on experience with laboratory instrumentation, including HPLC, GC, FT-IR, UPLC, and UV-VIS Spectrophotometers, among others. My technical expertise has enabled me to improve calibration processes, enhancing the reliability of instrumentation and reducing downtime significantly. I have also demonstrated strong cross-functional collaboration, working closely with teams across departments to resolve technical challenges and maintain the highest standards of quality control.
Among my achievements, I have led Maiva quality control team through multiple US-FDA and EU-GMP audits, consistently achieving positive outcomes with zero critical observations. My ability to streamline SOP processing, conduct thorough analytical method validations, and coordinate with cross-functional teams has contributed to the efficiency and success of my projects.
I am confident that my background in quality control, regulatory compliance, and analytical testing aligns with the needs of your organization. I am excited about the opportunity to contribute my expertise to your team and support the continued success of your operations. I welcome the chance to discuss how my experience can benefit your company in more detail.
Thank you for considering my application. I look forward to the opportunity to speak with you.
Sincerely,
S. Ruban Prakash
+91 9489592005 / 8838698607
s.rubanprakash@gmail.com