Job Description

ChatGPTLog inYou said:Jd for qc microbiologist in pharma manufacturing unitChatGPT said:

Below is a

(JD) for a QC Microbiologist

in a

pharmaceutical manufacturing unit

. You can copy, edit, or ask me to tailor it to your company, experience level, regulatory region (US FDA, EU GMP, WHO, MHRA), or dosage forms.

- QC Microbiologist (Pharmaceutical Manufacturing Unit)Position Title:

QC Microbiologist

Department:

Quality Control - Microbiology

Reports to:

QC Microbiology Manager / QC Head

Location:

Pharmaceutical Manufacturing Facility

1. Job Purpose

To conduct microbiological testing of raw materials, water, in-process samples, finished products, and environmental samples to ensure compliance with regulatory guidelines and maintain product quality and safety.

2. Key ResponsibilitiesA. Microbiological Testing

Perform

Sterility Testing

,

Bacterial Endotoxin Testing (BET/LAL)

,

Microbial Limit Tests (MLT)

,

Bioburden analysis

, and

Microbial identification

. Execute

Growth Promotion Tests (GPT)

for media. Conduct

Environmental Monitoring (EM)

of production areas: Settle plates Active air sampling Surface and personnel monitoring Compressed air/gas testing Perform

Water testing

(PW, WFI, utility water): TVC Endotoxin Conductivity TOC (if required)

B. Documentation & Compliance

Prepare and maintain

SOPs, STPs, GTPs, and logbooks

. Ensure all activities comply with

cGMP, GLP, GDP

, and regulatory guidelines. Record data in

Good Documentation Practice

format (ALCOA+ principles). Participate in

investigations

, including OOS, OOT, deviations, and CAPA implementation.

C. Instrument Operation & Maintenance

Operate and calibrate instruments such as: Laminar Air Flow (LAF) Incubators Autoclaves Biological safety cabinets pH meter Colony counter Microscopes Endotoxin testing systems (e.g., Kinetic LAL reader) Ensure proper qualification: IQ, OQ, PQ compliance.

D. Validation Activities

Participate in: Method validation Disinfectant efficacy studies Media fill (aseptic process simulation) Water system validation/monitoring Cleaning validation (micro level)

E. Training & Continuous Improvement

Follow and execute training on microbiological techniques. Suggest process improvements to enhance laboratory efficiency and compliance. Support regulatory inspections (FDA, WHO, MHRA, PIC/S, etc.).

3. Qualifications

B.Sc / M.Sc in Microbiology / Biotechnology

(or related discipline). 0-5+ years of QC microbiology experience in a pharmaceutical manufacturing environment (Tablets, OSD.).
Job Types: Full-time, Part-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Work Location: In person