Pharma / Intermediates QC Laboratory Assistant

About the Role

The role involves executing rigorous analytical testing, maintaining thorough documentation, and managing laboratory workflows aligned with Good Manufacturing Practice (GMP) standards.

Key Responsibilities

• Perform chemical assays and instrumental analyses including HPLC, GC, UV spectrometry, complemented by wet chemistry methods such as titration, Karl Fischer moisture determination, and loss on drying (LOD).
• Conduct tests conforming to various pharmacopoeial standards including USP, EP, IP, and BP where relevant.
• Assist in validation of analytical methods, transfer protocols, and stability testing programs.
• Uphold strict adherence to Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLP).
• Generate Certificates of Analysis (COAs) and ensure proper record maintenance.
• Manage calibration and routine upkeep of laboratory instruments, taking responsibility for instrument qualification schedules including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Possess working knowledge of validation processes and Drug Master File (DMF) related documentation.
• Act as the laboratory representative during client and regulatory audits to ensure compliance and provide required information.

Qualifications and Skills

• Educational background with a Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm) or Chemistry (B.Sc/M.Sc).
• Two to three years of direct experience working in Quality Control laboratories within the pharmaceutical or chemical manufacturing sectors.
• Competent in using analytical instrumentation and extensive documentation practices.
• Experience in pharmacopoeial testing, method validation, method transfer, as well as conducting stability studies is essential.
• Familiarity with instrument qualification procedures (IQ,OQ,PQ) and taking ownership of equipment calibration.

Eligibility

Individuals holding degrees in B.Pharm with specialization in Pharmaceutical Analysis and Quality Assurance or B.Sc in Chemistry are eligible to apply.