Conduct comprehensive chemical analyses on pharmaceutical compounds using advanced techniques such as HPLC, GC, FTIR, UV-Vis spectroscopy, and wet chemistry methods to assess their quality, purity, and stability.
Execute rigorous method validation and stability studies in accordance with established protocols and regulatory guidelines to ensure the accuracy and reliability of analytical results.
Take ownership of maintaining and troubleshooting analytical instrumentation, ensuring their proper functioning and reliability to uphold the integrity of analytical data.
Document all testing procedures, results, and observations meticulously in laboratory notebooks and electronic systems, maintaining a clear and accurate record of analytical activities.
Investigate out-of-specification (OOS) results and non-conformances with a keen attention to detail, actively participating in root cause analysis and contributing to corrective/preventive action (CAPA) plans.
Collaborate closely with R&D, manufacturing, and quality assurance teams to provide analytical support for product development, process optimization, and quality improvement initiatives.
Adhere strictly to cGMP guidelines, safety protocols, and company policies and procedures to maintain a compliant and safe working environment.
Stay abreast of industry trends, regulatory requirements, and advancements in analytical techniques through continuous learning, attending seminars, and reviewing relevant literature.
Mentor and train junior laboratory staff on analytical techniques, instrumentation operation, and best laboratory practices, fostering their professional development and ensuring consistency in analytical procedures.
Qualifications:
Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field.
Previous experience working in a pharmaceutical QC laboratory, preferably in a GMP-regulated environment.
Proficiency in a wide range of analytical techniques including HPLC, GC, FTIR, UV-Vis spectroscopy, and wet chemistry methods.
Strong understanding of pharmaceutical quality systems, regulatory requirements (e.g., FDA, EMA), and industry standards.
Ability to effectively manage multiple tasks and priorities in a fast-paced environment.
Familiarity with data analysis software and laboratory information management systems (LIMS) is advantageous.