Executive-Manager For Quality Control,Microbiology For API Pharma ABAD

Success Vibrant Hr & Pr Solutions; Dholka, Bavla; On-site; INR 600,000 - 1,100,000; Full time

Job summary

API Pharma Co in Ahmedabad seeks an experienced Quality Control Microbiologist to join as Executive-Manager. The role covers routine and non-routine microbiological analysis for raw materials, in-process samples, finished API products, and water systems, with emphasis on GPT and validation support.

The candidate will ensure compliance with cGMP, GLP, and global guidelines (USFDA, EU-GMP, WHO), handling OOS/OOT investigations and Maintaining GDP-aligned documentation.

Qualifications

• Experience in QC microbiology in API/pharma manufacturing.
• Knowledge of aseptic techniques and microbial testing.
• Familiarity with GDP and laboratory documentation practices.

Responsibilities

• Microbiological testing of raw materials, in-process samples, finished API products, and water systems (potable, purified water, and water for injection).
• Media preparation, sterilization cycles, and growth promotion tests (GPT).
• Environmental monitoring in cleanrooms and manufacturing blocks (air sampling, surface swabbing, settle plates).
• Assist in method validation, MLT, BET, and sterility programs where applicable.
• Maintain notebooks/logs and quality formats per GDP; investigate OOS/OOT deviations.

Skills

Aseptic techniques

Microbiology

Water testing

Instrument calibration

Documentation

Job description

We are looking for Quality Control & Microbiologist in API Pharma Co as Executive-Manager

The job description for a Quality Control (QC) Microbiologist in an Active Pharmaceutical Ingredient (API) Pharma Company in Ahmedabad typically involves the following core responsibilities, requirements, and compliance standards:

Key Responsibilities

• Microbiological Testing: Perform routine and non-routine microbiological analysis of raw materials, in-process samples, finished API products, and water systems (potable, purified water, and water for injection).
• Media Preparation & Sterilization: Handle media preparation, sterilization cycles, and execute Growth Promotion Tests (GPT).
• Environmental Monitoring (EM): Conduct routine environmental and personnel monitoring in cleanrooms, utility areas, and manufacturing blocks (air sampling, surface swabbing, settle plates).
• Method Validation & Support: Assist in microbiological method validation, microbial limit tests (MLT), bacterial endotoxin tests (BET), and sterility assurance programs where applicable.
• Documentation & Investigation: Maintain laboratory notebooks, logs, and quality formats in line with GDP (Good Documentation Practices). Investigate and document Out-Of-Specification (OOS), Out-Of-Trend (OOT) results, and laboratory deviations.
• Compliance & Audits: Ensure strict adherence to cGMP (Current Good Manufacturing Practices), GLP (Good Laboratory Practices), and global regulatory guidelines (USFDA, EU-GMP, WHO). Experience: Generally ranges from 2 to 6+ years of hands-on experience specifically within API / Bulk Drug or sterile pharmaceutical manufacturing quality control labs.Technical Knowledge: Strong command over aseptic techniques, microbial identification, water testing, and calibration of microbiology laboratory instruments.
• Location Preference: Local candidates based in Ahmedabad or surrounding industrial belts (such as Changodar, Bavla, or Naroda) are frequently preferred by regional firms. Role & responsibilities

Preferred candidate profile

Experienced in to QC-Microbiology for 03 to 09 years in API Pharma