– 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.
1. 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.

1. 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.

1. 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.

1. 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.

1. Behavioral Competencies

- Positive 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.

1. 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.

1. 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

📌 HPLC EXECUTIVE (Baddi)
🏢 AZENTYX HEALTHCARE
📍 Baddi