Quality Control - API Division - Visakhapatnam, Andhra Pradesh

Apitoria Pharma; Visakhapatnam; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Apitoria Pharma in Visakhapatnam is seeking a quality-focused professional to lead microbiology testing and analytical activities across materials and APIs.

You will perform microbiological testing as well as HPLC and GC analyses, maintaining documentation under cGMP, ICH, WHO, and USFDA guidelines.

This role requires a Master’s degree and 3–6 years of experience, emphasizing deviations, CAPA, audits, and SOPs within a robust Quality Management System.

Qualifications

• Master's degree in Microbiology, Chemistry, or B. Pharmacy.
• 3–6 years of experience.
• Experience with quality management and regulatory standards.

Responsibilities

• Perform microbiological testing of raw materials, purified water, environmental monitoring samples, compressed air, and finished APIs according to procedures.
• Conduct microbial limit tests, bioburden testing, endotoxin testing, and microbial identification.
• Monitor and trend environmental monitoring results for cleanrooms and controlled areas.

Skills

Microbiology testing

Environmental monitoring

Quality control

Education

M.Sc. in Microbiology / Chemistry / B. Pharmacy

Tools

HPLC

GC

QMS

Job description

Qualifications & Experience:

• Master's Degree (M.Sc.) in Microbiology / Chemistry & B. Pharmacy
• Experience : 3-6Yrs

Microbiology:

• Perform microbiological testing of raw materials, purified water, environmental monitoring samples, compressed air, and finished APIs as per approved procedures.
• Conduct microbial limit tests, bioburden testing, endotoxin testing, and microbial identification.
• Monitor and trend environmental monitoring results for cleanrooms and controlled areas.

HPLC & GC Analysis:

• Perform analysis of raw materials, intermediates, and APIs using HPLC & GC
• Prepare mobile phases, standard solutions, and test solutions according to approved methods.
• Execute method verification, method transfer, and instrument calibration activities.

Quality Management System (QMS):

• Manage deviations, change controls, CAPA, incident investigations, and risk assessments.
• Participate in internal audits and regulatory inspections.
• Prepare, review, and update SOPs, specifications, protocols, and reports.
• Ensure compliance with cGMP, ICH, WHO, USFDA, MHRA, and other regulatory requirements.