Quality Control Chemist

Description:

Key Responsibilities:

• 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.