Kadispark Consult Limited is a professional consulting firm specializing in Human Resource Management, Corporate Training, Business Advisory, and Organizational Development services. The company is committed to helping businesses improve workforce productivity, strengthen organizational performance, and achieve sustainable growth through innovative people-management solutions.
Our services include recruitment and talent acquisition, performance management, employee training and development, strategic human resource management, organizational restructuring, policy development, business registration support, corporate compliance advisory, and management consulting.
Kadispark also provides professional capacity-building programs in Project Management Professional (PMP), Health, Safety and Environment (HSE), Strategic Human Resource Management (SHRM), leadership development, and workplace effectiveness, equipping individuals and organizations with the skills required to compete in today's dynamic business environment.
Job Summary
- The Chemistry Analyst is responsible for performing chemical and instrumental analysis of raw materials, packaging materials, in-process samples, stability samples, and finished pharmaceutical products.
- The role ensures compliance with current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP), regulatory requirements, and company quality standards.
Key Responsibilities
Analytical Testing:
- Perform routine and non-routine chemical analysis of raw materials, intermediates, bulk products, and finished products.
- Conduct testing using analytical instruments such as:
- HPLC (High Performance Liquid Chromatography)
- GC (Gas Chromatography)
- UV-Visible Spectrophotometer
- FTIR Spectrometer
- Dissolution Apparatus
- Karl Fischer Titrator
- pH Meter and Conductivity Meter
- Perform assay, related substances, content uniformity, dissolution, identification, and impurity testing according to approved specifications and methods.
Laboratory Operations:
- Prepare reagents, volumetric solutions, standards, and mobile phases.
- Ensure proper calibration, qualification, and routine maintenance of laboratory instruments.
- Maintain laboratory equipment logbooks and records.
- Ensure compliance with laboratory housekeeping and safety requirements.
Documentation & Compliance:
- Record analytical data accurately in laboratory notebooks, worksheets, and electronic systems.
- Review test results and prepare Certificates of Analysis (COA).
- Follow Standard Operating Procedures (SOPs), cGMP, GLP, and data integrity requirements.
- Participate in internal and external audits and regulatory inspections.
Investigation & Troubleshooting:
- Investigate Out-of-Specification (OOS), Out-of-Trend (OOT), and laboratory deviations.
- Assist in root cause analysis and implementation of Corrective and Preventive Actions (CAPA).
- Support laboratory investigations and change control activities.
Stability Studies:
- Perform stability testing of pharmaceutical products according to approved stability protocols.
- Monitor and document stability trends.
- Support product shelf-life determination studies.
Method Validation & Transfer:
- Assist in analytical method validation, verification, and transfer activities.
- Participate in method development and optimization projects when required.
Key Performance Indicators (KPIs)
- Timely completion of analytical testing.
- Accuracy and reliability of laboratory results.
- Compliance with cGMP and regulatory requirements.
- Reduction in laboratory deviations and OOS occurrences.
- Instrument uptime and maintenance compliance.
- Timely closure of investigations and CAPAs.
Qualifications
Education:
- Bachelor's Degree in Chemistry, Analytical Chemistry, Industrial Chemistry, Pharmaceutical Chemistry, Biochemistry, or a related scientific discipline.
Experience:
- 1–5 years of experience in a pharmaceutical QC laboratory.
- Experience working in a cGMP-regulated environment is preferred.
- Knowledge of pharmacopeial requirements such as:
- United States Pharmacopeia (USP)
- British Pharmacopoeia (BP)
- European Pharmacopoeia (Ph. Eur.)
Required Skills:
- Strong knowledge of analytical chemistry principles.
- Hands-on experience with HPLC, GC, UV, FTIR, and dissolution testing.
- Understanding of cGMP, GLP, and data integrity requirements.
- Excellent documentation and reporting skills.
- Strong analytical and problem-solving abilities.
- Attention to detail and commitment to quality.
- Good communication and teamwork skills.