The QC Chemist will play a key role in ensuring the quality and compliance of raw materials, intermediates, APIs, excipients, and finished pharmaceutical products. The role requires performing analytical tests and maintaining laboratory compliance in accordance with Good Manufacturing Practices (GMP), regulatory guidelines, and company quality standards.
Key Responsibilities:
Sample Analysis:
Conduct routine and non-routine analysis of raw materials, intermediates, APIs, excipients, and finished products.
Perform chemical and instrumental analysis using techniques such as HPLC, GC, FTIR, UV-Vis spectroscopy, and titration.
Documentation:
Maintain accurate and detailed documentation of laboratory activities, test results, and findings as per GMP standards.
Prepare and review analytical test reports, certificates of analysis (CoA), and Standard Operating Procedures (SOPs).
Instrument Calibration and Maintenance:
Calibrate, maintain, and troubleshoot laboratory instruments to ensure their proper functioning.
Maintain logs for instrument calibration and preventive maintenance.
Compliance and Quality Assurance:
Ensure all laboratory activities comply with GMP, regulatory guidelines (e.g., ICH, USP, Ph. Eur.), and company protocols.
Participate in internal and external audits and support investigations related to quality incidents or deviations.
Support for Method Validation:
Assist in method development, validation, and transfer as required.
Perform stability studies as per ICH guidelines.
Hygiene and Safety:
Ensure proper maintenance of the laboratory environment, including cleanliness, safety, and waste disposal.
Follow all safety guidelines while handling chemicals and laboratory equipment.
Collaboration:
Work closely with production, R&D, and quality assurance teams to resolve quality issues.
Provide analytical support during process validation and troubleshooting.
Required Skills and Competencies:
Technical Proficiency:
Strong knowledge of analytical techniques such as HPLC, GC, FTIR, UV-Vis, and wet chemistry methods.
Familiarity with regulatory guidelines (e.g., ICH, USP, FDA, EMA) and GMP requirements.
Attention to Detail:
High level of accuracy and precision in laboratory testing and documentation.
Problem-Solving Skills:
Ability to troubleshoot analytical issues and recommend solutions.
Communication and Teamwork:
Effective communication skills to coordinate with cross-functional teams and document findings clearly.
Computer Literacy:
Proficiency in software tools such as LIMS, Chromeleon, or similar analytical software.
Familiarity with MS Office (Word, Excel, PowerPoint).
Qualifications:
Education: Bachelor's or Master's degree in Chemistry, Pharmaceutical Chemistry, or related field.
Certifications (Optional): Training or certification in GMP, HPLC/GC operation, or regulatory compliance is an advantage.
Work Environment:
Laboratory-based role requiring adherence to safety and hygiene protocols.
May require occasional shifts or extended working hours to meet production timelines.
Why Join Us?
Opportunity to work with a leading pharmaceutical company specializing in APIs and excipients.
Exposure to cutting-edge analytical technologies and a highly collaborative work environment.
Competitive salary and professional development opportunities.
Job Types: Full-time, Fresher
Pay: ?12,000.00 - ?13,000.00 per month
Benefits:
Health insurance
Work Location: Remote
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