Senior Quality Control Analyst HPLC

JOB DESCRIPTION QUALITY CONTROL ANALYST (HPLC EXPERT)

Company: VIP Pharmaceuticals Pvt. Ltd.
Location: Village Manpura, Tehsil Nalagarh, Distt. Solan, Himachal Pradesh
Department: Quality Control
Reporting to: QC Manager / QC Head
Employment: Full-time, plant-based

Role Overview

We are looking for a technically competent QC Analyst with strong hands-on HPLC expertise and experience in complete chemical and instrumental analysis of tablets and capsules. The candidate should independently perform routine and stability testing, troubleshoot analytical issues, and maintain accurate laboratory records according to approved specifications, STPs and SOPs.

Key Responsibilities

• Perform analysis of semi-finished and finished tablets and capsules, including routine, validation and stability samples.
• Independently operate HPLC systems, prepare analytical sequences, assess system suitability, process chromatograms and calculate results.
• Conduct HPLC testing for assay, related substances, impurities, content uniformity and dissolution samples, as applicable to the product specification.
• Prepare mobile phases, buffers, diluents, standard solutions and sample solutions accurately.
• Perform applicable tests such as identification, dissolution, disintegration, uniformity of dosage units, weight variation, friability, hardness, moisture and other specification requirements.
• Operate relevant laboratory instruments, including UV-Visible spectrophotometer, FTIR, dissolution apparatus, Karl Fischer titrator, analytical balance and pH meter.
• Troubleshoot HPLC problems such as abnormal pressure, leakage, baseline noise, retention-time shifts, poor peak shape, carryover and system-suitability failures.
• Maintain proper HPLC column conditioning, flushing, storage and usage records.
• Follow approved integration procedures and maintain complete chromatographic data, including processing history and audit trails.
• Prepare analytical worksheets, calculations, instrument logbooks and supporting records for certificates of analysis.
• Immediately report OOS/OOT results, deviations and instrument abnormalities; support documented investigations without unauthorized retesting or data alteration.
• Support analytical method verification, validation and transfer activities as assigned.
• Follow instrument calibration schedules, reference/working-standard controls, reagent validity and laboratory safety procedures.
• Complete assigned testing within planned timelines and support laboratory audits and inspections.

Qualification

B.Sc./M.Sc. in Chemistry or Analytical Chemistry, or B.Pharm./M.Pharm., with relevant pharmaceutical QC experience.

Experience

Preferably 3–6 years in pharmaceutical formulation QC, with substantial independent HPLC experience in tablet and capsule analysis.

Essential Skills

• Strong practical knowledge of HPLC operation, chromatography, troubleshooting and analytical calculations.
• Experience testing single-ingredient and combination formulations.
• Ability to interpret and follow approved IP/BP/USP methods and in-house STPs.
• Sound understanding of GMP, GLP, data integrity and good documentation practices.
• Experience with chromatography software; familiarity with Thermo Scientific HPLC systems and Chromeleon will be an advantage.
• Ability to handle routine analytical work independently and coordinate effectively with the QC team.

Selection Criteria

Candidates should be able to demonstrate practical HPLC competence, including solution preparation, dilution calculations, chromatogram interpretation, system-suitability assessment and troubleshooting.

Salary: Commensurate with experience and demonstrated technical competency.