Quality Control Officer- Micro

Sterling Healthcare; Pune District; On-site; INR 800,000 - 1,100,000; Full time

Job summary

Sterling Healthcare Ltd. Pune seeks a Quality Control Officer (Microbiology) to execute microbiological testing and QC activities for the OSD manufacturing facility, ensuring compliance with GMP, GLP, GDP, SOPs and pharmacopoeial requirements.

The role requires 4 years in Pharmaceutical QC Microbiology, with hands-on testing of MLT, EM, water systems and bioburden, plus strong documentation and data integrity practices. OSD/Formulations exposure preferred; reporting to QA/QC leadership.

Qualifications

• 04 years of experience in Pharmaceutical QC Microbiology.
• Experience in OSD/Formulations manufacturing preferred.
• Strong knowledge of GMP/cGMP, GLP, GDP and Data Integrity.
• Hands-on experience in MLT, Environmental Monitoring, Water Testing, Bioburden and GPT.
• Knowledge of IP, BP, USP and Ph. Eur. requirements.
• Experience in OOS/OOT, Deviations, CAPA and Root Cause Analysis.
• Good documentation, analytical, communication and problem-solving skills.

Responsibilities

• Perform microbiological testing of raw materials, in-process samples, finished products and stability samples.
• Perform Microbial Limit Testing (MLT), microbial enumeration, specified microorganism testing and bioburden testing.
• Perform microbiological testing of Purified Water and pharmaceutical water systems.
• Execute Environmental Monitoring (EM) including active air sampling, settle plates, surface monitoring and personnel monitoring.
• Prepare culture media, reagents and solutions and perform Growth Promotion Testing (GPT).
• Maintain microbial cultures, reference strains, laboratory records and microbiology documentation.
• Operate and maintain microbiology laboratory equipment, incubators, autoclaves and related instruments.
• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and ALCOA+ data integrity.
• Participate in OOS, OOT, deviation, environmental monitoring excursion and CAPA investigations.
• Support root cause analysis, microbiological trend analysis and timely closure of investigations.
• Support stability, validation, method suitability/verification and other microbiological activities.
• Ensure laboratory housekeeping, safety, biosafety and proper disposal of microbiological waste.
• Coordinate with QA, Production, Engineering and QC for timely completion of testing and investigations.
• Support internal audits, customer audits and regulatory inspections.

Skills

GMP/cGMP knowledge

GLP understanding

GDP and Data Integrity

Environmental Monitoring

MLT and GPT techniques

Analytical thinking

Documentation & record keeping

Education

B.Sc./M.Sc. Microbiology

Tools

Incubators

Autoclaves

Bioburden testing instruments

Water testing equipment

Job description

QUALITY CONTROL OFFICER MICROBIOLOGY

Department: Quality Control Microbiology
Location: Sterling Healthcare Ltd Pune, Maharashtra
Experience: 04 Years
Qualification: B.Sc./M.Sc. Microbiology

Industry: Pharmaceutical Formulations OSD
Reporting To: Manager / Assistant Manager Quality Control

JOB SUMMARY

Responsible for execution of microbiological testing and Quality Control activities for the Oral Solid Dosage (OSD) manufacturing facility, ensuring compliance with GMP, GLP, GDP, SOPs, pharmacopoeial requirements and ALCOA+ data integrity principles.

KEY RESPONSIBILITIES

• Perform microbiological testing of raw materials, in-process samples, finished products and stability samples as per approved specifications and SOPs.
• Perform Microbial Limit Testing (MLT), microbial enumeration, specified microorganism testing and bioburden testing.
• Perform microbiological testing of Purified Water and pharmaceutical water systems.
• Execute Environmental Monitoring (EM) including active air sampling, settle plates, surface monitoring and personnel monitoring.
• Prepare culture media, reagents and solutions and perform Growth Promotion Testing (GPT).
• Maintain microbial cultures, reference strains, laboratory records and microbiology documentation.
• Operate and maintain microbiology laboratory equipment, incubators, autoclaves and related instruments.
• Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and ALCOA+ data integrity.
• Participate in OOS, OOT, deviation, environmental monitoring excursion and CAPA investigations.
• Support root cause analysis, microbiological trend analysis and timely closure of investigations.
• Support stability, validation, method suitability/verification and other microbiological activities.
• Ensure laboratory housekeeping, safety, biosafety and proper disposal of microbiological waste.
• Coordinate with QA, Production, Engineering and QC for timely completion of testing and investigations.
• Support internal audits, customer audits and regulatory inspections.

REQUIRED EXPERIENCE & SKILLS

• 04 years of experience in Pharmaceutical QC Microbiology.
• Experience in OSD/Formulations manufacturing preferred.
• Strong knowledge of GMP/cGMP, GLP, GDP and Data Integrity.
• Hands-on experience in MLT, Environmental Monitoring, Water Testing, Bioburden and GPT.
• Knowledge of IP, BP, USP and Ph. Eur. requirements.
• Experience in OOS/OOT, Deviations, CAPA and Root Cause Analysis.
• Good documentation, analytical, communication and problem-solving skills.
• Strong attention to detail and quality/compliance mindset.