Job Description

Job Title:

Quality Control Executive - Finished Product (Chemical Testing)

Department:

Quality Control (QC)

Location:

[Insert Location]

Reports to:

QC Manager / Quality Head

Experience Required:

2-5 years in pharmaceutical/chemical industry

Qualification:

B.Sc. / M.Sc. (Chemistry), B.Pharm / M.Pharm

Job Purpose:

Responsible for sampling and chemical analysis of finished pharmaceutical products, ensuring compliance with standard operating procedures (SOPs), regulatory standards (ICH), and internal quality specifications using techniques such as HPLC, UHPLC, GC, and wet chemistry.

Key Responsibilities:1. Sampling & Testing

Perform

sampling of finished products

as per approved SOPs. Conduct

chemical analysis

using validated analytical methods (wet chemistry and instrumental methods like HPLC, UHPLC, GC). Ensure all tests are conducted in accordance with

Analytical Data Sheets

and

test methods

.

2. Documentation & Compliance

Prepare and maintain test records,

COAs (Certificate of Analysis)

,

WRS (Working Reference Standards)

logbooks, and

Analytical Data Sheets

. Maintain raw data and ensure timely review and approval of results. Adhere to

ICH Q2/Q6

guidelines for method validation and product specifications.

3. Investigation & Reporting

Handle

OOS (Out of Specification)

and

OOC (Out of Trend)

results, including root cause analysis, CAPA implementation, and documentation. Participate in

Deviation, Change Control (DC), and Corrective/Preventive Actions (CAPA)

processes.

4. Instrument Operation & Calibration

Operate and troubleshoot

HPLC, UHPLC, GC

, UV, and other analytical instruments. Ensure instruments are calibrated and maintained as per AMC (Annual Maintenance Contract) schedules.

5. Stability & Regulatory Compliance

Perform

stability studies

on finished products as per

ICH guidelines

and ensure timely reporting. Contribute to

CSR (Comparative Study Report)

and

regulatory documentation

when required.

6. Review & Audit

Conduct peer reviews of analytical documents. Assist during internal and external audits (e.g., USFDA, WHO, MHRA). Ensure GMP and GLP compliance in the QC lab.

Required Skills:

In-depth knowledge of analytical techniques (HPLC, GC, wet chemistry) Understanding of

ICH guidelines

,

GMP/GLP

,

OOS/OOC handling

Good documentation practices and data integrity awareness Proficient in analytical software (Empower, LabSolutions, Chromeleon preferred)
Job Types: Full-time, Permanent

Pay: ?300,000.00 - ?600,000.00 per year

Benefits:

Food provided Health insurance * Provident Fund