HPLC EXECUTIVE

JOB DESCRIPTION – HPLC EXECUTIVE

Company: Azentyx Health Care Pvt. Ltd.
Department: Quality Control (QC)
Designation: HPLC Executive
Location: Baddi, Himachal Pradesh
Reporting To: QC Manager / Head – Quality Control

1. Job Purpose

To perform HPLC analysis of raw materials, in-process samples, finished products, stability samples, and other pharmaceutical samples in accordance with approved specifications, analytical methods, SOPs, GMP, GLP, and data integrity requirements.

2. Key Responsibilities

• Perform routine HPLC analysis of pharmaceutical samples as per approved analytical methods and specifications.
• Operate, maintain, and troubleshoot HPLC instruments and associated equipment.
• Perform system suitability tests before analysis and ensure compliance with acceptance criteria.
• Prepare mobile phases, diluents, standards, and sample solutions as per approved procedures.
• Perform calibration, verification, and routine maintenance of HPLC instruments.
• Review chromatograms, integration, calculations, and analytical results for accuracy.
• Maintain complete and accurate analytical records, worksheets, logbooks, and instrument usage records.
• Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
• Investigate OOS, OOT, atypical results, and analytical discrepancies in coordination with the QC team.
• Support method validation, method verification, method transfer, and analytical method development activities, where applicable.
• Perform cleaning and routine checks of HPLC instruments and laboratory equipment.
• Ensure compliance with GMP, GLP, SOPs, pharmacopoeial requirements, and ALCOA+ data integrity principles.
• Maintain proper documentation of standards, reagents, solvents, columns, and consumables.
• Coordinate with Production, QA, and other departments whenever required for analytical activities.
• Participate in internal audits, regulatory inspections, investigations, CAPA, and other quality-related activities.
• Ensure laboratory safety practices while handling chemicals, solvents, and pharmaceutical samples.

3. Qualification

Required:

• B.Sc./M.Sc. in Chemistry, Pharmaceutical Chemistry, Analytical Chemistry, or related discipline.
• B.Pharm/M.Pharm candidates with relevant analytical laboratory experience may also be considered.

4. Experience

• 2–5 years of relevant experience in a pharmaceutical QC laboratory.
• Hands-on experience in HPLC analysis is mandatory.
• Experience in handling other instruments such as GC, UV, dissolution, and IR will be an added advantage.

5. Technical Skills

• Good knowledge of HPLC principles, operation, and troubleshooting.
• Knowledge of analytical method, system suitability, and chromatographic parameters.
• Understanding of pharmacopoeial requirements such as IP, BP, USP, and Ph. Eur.
• Knowledge of GMP, GLP, SOPs, OOS/OOT investigation, and data integrity.
• Good documentation and analytical calculation skills.
• Basic knowledge of chromatography software and electronic data handling.

6. Behavioral Competencies

• Good analytical and problem-solving skills.
• Attention to detail and accuracy.
• Good communication and coordination skills.
• Ability to work independently as well as in a team.
• Strong commitment to quality and compliance.
• Ability to work under deadlines and manage multiple analytical activities.

7. Key Performance Indicators (KPIs)

• Accuracy and reliability of analytical results.
• Timely completion of testing.
• Compliance with approved SOPs and specifications.
• Proper documentation and data integrity.
• Instrument utilization and maintenance.
• Timely closure of OOS/OOT and analytical investigations.
• Compliance with GMP/GLP requirements.

8. Authority

The HPLC Executive shall have the authority to:

• Stop or hold analysis when abnormal instrument performance or testing conditions are observed.
• Report analytical discrepancies and suspected non-conformities to the QC Manager.
• Recommend instrument maintenance or troubleshooting whenever required.
• Reject analytical data that does not meet approved procedures or data integrity requirements, subject to QC management review.

Pay: ₹15,029.42 - ₹32,563.62 per month

Benefits:

• Flexible schedule
• Food provided
• Health insurance
• Leave encashment
• Paid sick time
• Provident Fund

Work Location: In person