Provide technical expertise, review, and assessment for the development of software qualification protocols for laboratory equipment.
Collaborate with instrument and software vendors to gather necessary information and troubleshoot issues.
Execute laboratory equipment software qualification protocols, ensuring adherence to good documentation practices and providing objective evidence.
Prepare required testing materials, standards, and other resources to carry out protocol executions effectively.
Assist in investigating protocol deviations and conduct root cause analysis.
Develop corrective actions for anomalies or deviations related to qualification protocols.
Work collaboratively with the Data Integrity and Laboratory teams to achieve project goals.
Work independently while managing your workload efficiently.
Prioritize and organize projects in a structured and systematic manner.
Stay updated on federal and international regulations related to analytical chemistry and cGMP standards, while proactively leading validation and optimization initiatives.
Help maintain quality control records, including equipment/instrument specifications, drawings, protocols, and validation reports, ensuring control of all processes, systems, and equipment.
Qualifications:
Bachelor’s degree in Chemistry or a related field.
Three or more years of experience working with laboratory equipment in a regulated environment.
Preferred experience in the pharmaceutical industry.
Proficient in using laboratory instruments such as Analytical Balance, pH meter, automatic pipettes, FTIR, UV-Vis, Voltammeter, Autotitrator, ICP, Flame AA, TOC, Conductivity meter.
Strong understanding of GMP regulations, Data Integrity standards, and Good Documentation Practices related to quality control laboratories.
Knowledge of regulatory and compendial guidelines for test procedures, equipment qualification, and validation.
Ability to work both independently and as part of a team to achieve goals and meet priorities.
Capable of collaborating with other departments to identify solutions, resolve issues, and achieve compliant outcomes.
