Quality Control and Assurance

Bikesh Shrestha

***** * ***** **, ******** Park

**********@*****.*** 913-***-****

Professional Summary

Dedicated Quality Assurance and Control professional with extensive expertise in pharmaceutical analysis, documantation regulatory compliance, and laboratory instrumentation. Proficient in ISO 17025 standards, method validation, and process optimization to enhance product quality and operational efficiency. Proven leadership in cross-functional team management, training, and audit preparation.

Core Competencies

Analytical Testing & Techniques: Proficient in HPLC, GC, LC-MS, UV-Vis Spectroscopy, Dissolution Testing, and FTIR for pharmaceutical quality control and analysis.

Pharmaceutical Testing & Validation: Skilled in method validation, stability studies, and compliance with GLP (Good Laboratory Practices) and cGMP (current Good Manufacturing Practices).

Regulatory Compliance: Expertise in interpreting and applying USP, BP, and JP guidelines, with experience in ISO 17025 regulatory audits.

Data Analysis & Reporting: Experienced in statistical analysis, trend monitoring, and using LIMS to manage laboratory data. Adept at CAPA implementation for process optimization.

Instrumentation Expertise: Demonstrated ability in calibration, troubleshooting, and preventive maintenance of laboratory instruments to ensure accuracy and reliability.

Equipment Operation & Maintenance: Conducted preventative maintenance on testing equipment and related components to ensure operational efficiency.

Documentation & Auditing: Comprehensive knowledge of writing and maintaining SOPs, deviation reports, Certificates of Analysis, and audit preparation.

Soft Skills: Strong attention to detail, effective communication, collaboration across departments, leadership in training and mentoring, and managing complex laboratory projects.

Professional Experience

Zest Laboratories and Research Center Pvt Ltd — Bhaktapur, Nepal

Assistant Manager

October 2023 – October 2024

Developed and optimized analytical methods for testing the identity, strength, purity, and stability of pharmaceutical products, ensuring compliance with official compendial or in-house methods.

Directed cross-functional teams in preparing regulatory documentation and supporting successful internal and external audits.

Supervised, trained, and mentored junior staff in analytical techniques, SOP adherence, and proper documentation practices, enhancing team competency.

Investigated non-conformance and out-of-specification (OOS) results, conducting root cause analysis and implementing effective corrective and preventive actions (CAPA).

Managed comprehensive document control systems, ensuring accurate, timely, and secure handling of critical laboratory records in accordance with GMP standards.

Performed preventative maintenance and calibration on analytical instruments, minimizing downtime and ensuring testing accuracy.

Senior Quality Control Executive

April 2022 – October 2023

Developed strategies to improve efficiency, accuracy, and reliability in quality control processes through data-driven analysis.

Conducted aflatoxin and pesticide residue testing on food samples, adhering to stringent quality and safety standards.

Performed root cause analysis for laboratory investigations, identifying issues, and formulating corrective actions to prevent recurrence.

Coordinated internal and external audits, maintaining compliance with ISO 17025 and regulatory requirements.

Collaborated with research and production teams to develop innovative testing methods and ensure robust quality assurance.

Ensure accuracy and completeness of documentation while resolving any discrepancies promptly

Senior Quality Control Analyst

December 2017 – April 2022

Performed detailed quality control testing on raw materials, intermediates, and finished products using HPLC, GC, and other analytical techniques.

Monitored and documented stability studies, ensuring products met potency and safety requirements throughout shelf life.

Led equipment calibration, maintenance, and troubleshooting to uphold laboratory standards and prevent downtime.

Trained new hires in laboratory practices, equipment operation, and compliance with good documentation practices.

Conducted method development, transfer, and validation studies to support manufacturing and regulatory submissions.

Managed inventory for test equipment repairs, ensuring accurate documentation and proper transfer procedures.

Vijayadeep Laboratories Ltd — Lalitpur, Nepal

Quality Control Analyst

June 2015 – December 2017

Conducted comprehensive analysis of pharmaceutical products to ensure compliance with pharmacopoeial standards and regulatory guidelines.

Conduct batch release evaluations and generate Certificates of Analysis (CoA) and other required batch documentation in compliance with quality standards.

Performed routine water analysis, swab testing, and calibration of analytical instruments, maintaining stringent quality control.

Drafted, reviewed, and maintained accurate documentation of test procedures, results, and corrective actions.

Participated in risk assessments, method validations, and process improvements to enhance operational efficiency.

Ensure compliance of all product manufacturing aspects, including production, packaging, labeling, and testing, with established quality system specifications

Education

Master of Pharmacy (Industrial Pharmacy)

Kathmandu University, Dhulikhel, Nepal

Languages

Fluent in English, Hindi, and Nepali

Additional Skills

Adaptability: Quick learner with the ability to adjust to new technologies, environments, and regulatory requirements.

Effective Decision-Making: Applies innovative problem-solving strategies to drive operational efficiency and quality.

Communication & Leadership: Strong presenter and team leader, fostering a collaborative and results-oriented work environment.

Product Development Support: Assisted product teams with developing and introducing new products, creating product application documentation and presentations.

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