27 Oct
|
Success Vibrant Hr & Pr Solutions
|
Dholka
27 Oct
Success Vibrant Hr & Pr Solutions
Dholka
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 (Positive 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 Positive 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: Robust 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
📌 Executive Manager For Quality Control,microbiology For Api Pharma Abad Dholka
🏢 Success Vibrant Hr & Pr Solutions
📍 Dholka