Job Title: Quality Control Chemist HLL-IX
Location: Nakkapally, Anakapali, Andhra Pradesh, India
Department: Quality Control
Job Posted On: Feb 14, 2025
Employee Type: Outsourcing
Experience Range: Not Applicable (Entry-level position)
Key Responsibilities:
1. Sampling and Analysis:
Perform sampling of raw materials, intermediates, and finished Active Pharmaceutical Ingredients (APIs) as per standard procedures, ensuring compliance with quality assurance standards.
Conduct routine and non-routine chemical and physical tests to ensure the products meet predefined quality benchmarks.
Use analytical techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis spectroscopy, FTIR, and other instruments for product analysis.
2. Documentation:
Accurately document all test results, observations, and other relevant data in laboratory notebooks or electronic systems in a precise and systematic manner.
Prepare and review Certificates of Analysis (CoA) for finished products and intermediates to ensure they meet the required quality standards.
Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all testing procedures and documentation.
3. Compliance and Standards:
Follow established quality standards as outlined in pharmacopeias such as USP, BP, IP, EP, and ensure compliance with FDA, ICH, and WHO regulatory guidelines.
Participate in internal and external audits to ensure adherence to industry standards and implement corrective actions when required.
4. Instrument Calibration and Maintenance:
Perform regular calibration, qualification, and preventive maintenance of laboratory instruments to ensure they function within specifications.
Troubleshoot and resolve any issues with laboratory equipment, collaborating with the maintenance or engineering teams as needed.
5. Stability Studies:
Conduct stability studies for APIs to assess shelf life, storage conditions, and stability under various environmental conditions in compliance with ICH guidelines.
Monitor stability data and report findings to ensure API shelf-life predictions are accurate.
6. Deviations and Investigations:
Identify, investigate, and report deviations or Out-of-Specification (OOS) results, following proper investigation protocols.
Participate in root cause analysis to identify issues and offer recommendations for Corrective and Preventive Actions (CAPA).
7. Method Development and Validation:
Assist in the development, optimization, and validation of new analytical methods for APIs.
Support the transfer of validated methods to production and other QC teams for consistent implementation across departments.
8. Training and Knowledge Sharing:
Provide training to junior staff on quality control procedures, analytical techniques, and safety protocols to maintain high operational standards.
Stay updated on new analytical techniques, regulatory guidelines, and evolving quality standards in the pharmaceutical industry.
Qualifications and Skills:
Education:
Master’s degree in Analytical Chemistry, Organic Chemistry, or B. Pharmacy is required.
Technical Skills:
Proficiency in analytical techniques such as HPLC, GC, UV-Vis spectroscopy, FTIR, and titration is essential.
Familiarity with laboratory software such as Chromeleon, LabSolutions, or Empower is preferred.
Strong understanding of GMP, GLP, and regulatory requirements is critical.
Soft Skills:
Strong analytical and problem-solving skills to troubleshoot and resolve technical issues.
Excellent attention to detail and a commitment to maintaining the highest standards of quality.
Effective communication and documentation skills to ensure clear reporting and collaboration with team members and stakeholders.
Work Environment:
This is a laboratory-based role with exposure to chemicals and analytical instruments, requiring adherence to strict safety protocols.
The role may require flexible working hours to meet project deadlines or to address urgent testing and critical issues.
Key Performance Indicators (KPIs):
Accuracy and reliability of analytical results.
Timely completion of testing and reporting as per deadlines.
Compliance with GMP and GLP standards and readiness for audits.
Effective resolution of OOS results and deviations to ensure continuous product quality.
Summary:
The Quality Control Chemist role at HLL-IX is ideal for someone with a strong background in analytical chemistry and a keen eye for quality control processes in the pharmaceutical industry. The position offers hands-on experience in performing a range of analytical tests, maintaining documentation, conducting stability studies, and ensuring regulatory compliance. The ideal candidate should possess strong technical skills in instrumentation, method development, and troubleshooting, as well as the ability to train and guide junior team members in maintaining high-quality standards.
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