Job Title: QC Executive – (RM / FG / Stability / AMV & PV / Microbiology)

Location: Indore – Regulated Pharma Manufacturing Plant

Department: Quality Control

Reporting To: QC Manager / Head – Quality Control

Job Type: Full-Time | Executive Level

Job Purpose

To perform quality control testing and analysis of raw materials, finished products, stability samples, and microbiological parameters as per current Good Manufacturing Practices (cGMP), standard operating procedures (SOPs), pharmacopeial standards, and regulatory requirements to ensure product quality and compliance.

Key Responsibilities

Testing and Analysis

Perform chemical and instrumental testing of Raw Materials (RM) and Finished Goods (FG) as per pharmacopeial and in-house specifications.

Conduct Stability Studies in line with ICH guidelines and maintain records of stability trends.

Execute Analytical Method Validations (AMV) and support Process Validation (PV) testing.

Carry out Microbiological analysis of samples, including environmental monitoring, water testing, and microbial limit tests.





Documentation and Compliance

Maintain accurate, complete, and timely documentation (analytical reports, logbooks, LIMS/ERP entries).

Ensure compliance with cGMP, GLP, and regulatory standards (USFDA, EU-GMP, WHO, etc.).

Participate in internal audits, external regulatory inspections, and implement CAPAs.

Prepare and review standard operating procedures (SOPs), specifications, and testing protocols.

Equipment Operation & Calibration

Operate and calibrate instruments like HPLC, GC, UV, IR, Dissolution Apparatus, FTIR, etc.

Ensure timely preventive maintenance and validation of QC instruments.

Cross-functional Coordination

Coordinate with Production, QA, Regulatory Affairs, and other relevant departments to resolve testing issues and support product release timelines.

Participate in investigations of OOS/OOT results, deviations, and change controls.

Key Skills & Competencies

Sound knowledge of cGM

📌 QC Executive – (Ciudad de México)
🏢 SAVA HEALTHCARE
📍 Ciudad de México