Quality Control - API Division - Visakhapatnam, Andhra Pradesh

Apitoria Pharma; Visakhapatnam; On-site; INR 450,000 - 750,000; Full time

Job summary

Apitoria Pharma seeks a qualified professional to lead microbiology testing and HPLC analysis for raw materials, intermediates, and finished APIs. The role includes environmental monitoring, method verification, and instrument calibration in a cGMP/ICH/WHO-regulated environment.

The candidate should hold a MSc in Microbiology or Chemistry with 3–8 years of relevant experience and be familiar with regulatory inspections and quality management systems.

Qualifications

• Master's degree in Microbiology or Chemistry.
• 3–8 years of experience in related field.
• Experience with regulatory requirements (cGMP, ICH, WHO) preferred.

Responsibilities

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

Skills

Microbiology testing

Environmental monitoring

Analytical skills

Regulatory compliance

Education

Master's Degree (M.Sc.) in Microbiology / Chemistry

Tools

HPLC

Analytical instruments

Job description

Qualifications & Experience:

• Master's Degree (M.Sc.) in Microbiology / Chemistry
• Experience : 3-8Yrs

Job Description:

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 Analysis:

• Perform analysis of raw materials, intermediates, and APIs using HPLC and other analytical instruments.
• 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.