Job Summary
The Chemist is responsible for performing chemical analyses, testing raw materials, in-process samples, finished products, and stability samples to ensure compliance with company specifications, Good Manufacturing Practices (GMP), and regulatory requirements. The role supports manufacturing operations by maintaining product quality, investigating laboratory results, and ensuring accurate documentation.
Key Responsibilities
Perform chemical analysis of raw materials, intermediates, finished products, and stability samples using approved analytical methods.
Operate, calibrate, and maintain laboratory instruments such as HPLC, GC, UV-Vis Spectrophotometer, FTIR, pH meters, and analytical balances.
Prepare reagents, standards, and sample solutions according to established procedures.
Review and interpret analytical data, ensuring accuracy and compliance with specifications.
Document laboratory activities in accordance with Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), and company Standard Operating Procedures (SOPs).
Investigate out-of-specification (OOS), out-of-trend (OOT), and laboratory deviations as required.
Assist in method validation, method transfer, verification, and analytical troubleshooting.
Participate in laboratory investigations, corrective and preventive actions (CAPA), and continuous improvement initiatives.
Ensure compliance with health, safety, environmental, and quality regulations.
Support internal and external audits by providing laboratory documentation and technical information.
Collaborate with Production, Quality Assurance, Validation, and Regulatory Affairs teams to resolve quality-related issues.
Maintain laboratory cleanliness, organization, and inventory of chemicals and laboratory supplies.
Qualifications:
Bachelor's degree in Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, or a related scientific discipline.
Previous experience in a pharmaceutical manufacturing or quality control laboratory is preferred.
Knowledge of GMP, GLP, FDA, ICH, and other applicable regulatory guidelines.
Experience with chromatographic and spectroscopic analytical techniques is an advantage.
Strong analytical, problem-solving, and organizational skills.
Proficiency in Microsoft Office and laboratory data management systems.
Excellent written and verbal communication skills.
Preferred Skills
Experience with HPLC, GC, FTIR, UV-Vis spectroscopy, and dissolution testing.
Familiarity with Laboratory Information Management Systems (LIMS).
Knowledge of analytical method validation and stability testing.
Ability to work independently and collaboratively in a cross-functional team.
Strong attention to detail and commitment to data integrity.
Working Conditions
Laboratory-based position within a pharmaceutical manufacturing facility.
May require shift work, overtime, or weekend work based on production requirements.
Requires the use of appropriate personal protective equipment (PPE) and adherence to laboratory safety protocols.
Key Performance Indicators (KPIs)
Timely completion of laboratory testing.
Accuracy and reliability of analytical results.
Compliance with GMP, SOPs, and regulatory requirements.
On-time completion of documentation and reports.
Successful participation in audits and quality improvement initiatives.