Title: Deputy Manager - API Custom Field 2: 3061 Location: Bavla, Gujarat, IN Country/Region: IN State: Guja City: Bavla Company: Dishman Carbogen Amcis Limited Business Unit: General Travel Description: Preparation, review, issuance, and effective implementation of Standard Operating Procedures (SOPs) in compliance with regulatory requirements.

Review, approval, and management of OOS (Out of Specification), OOT (Out of Trend), Deviations, Incidents, CAPA, and Change Control to ensure timely closure and regulatory compliance.

Handling, monitoring, and documentation of control samples and retention samples.

Conducting and imparting internal trainings to DCAL employees on quality systems, SOPs, GMP, and regulatory expectations.

Review of Calibration Records and Instrument Logbooks of Quality Control laboratory instruments.

Review and approval of Analytical Method Validation (AMV) protocols and reports.

Review of Instrument Qualification and Re-qualification protocols (IQ, OQ, PQ) for QC laboratory equipment.

Preparation and review of Quality Risk Management (QRM) documents in line with ICH Q9.

Review and approval of analytical data for QA batch release and compliance confirmation.





Review and approval of Specifications, STPs, Raw Data Sheets, and related QC documentation.

Review of laboratory investigations related to complaints, deviations, OOS/OOT, and ensuring QC-related CAPAs are completed within defined timelines.

Participation in and compliance with Internal Audits and External Audits (Regulatory, Customer, and Certification audits).

Providing analytical and documentation support to Regulatory Affairs (RA) as required.

Review and monitoring of Working Standard management and Stability Studies in accordance with approved protocols.

Handling and investigation of customer complaints, deviations, incidents, and CAPAs related to QC activities.

Ensuring adherence to Safety, Health, and Setting (SHE) guidelines and proper use of Personal Protective Equipment (PPE) during laboratory and office work.

In the absence of Quality Systems personnel, performing Quality Systems-related activities to ensure continuous compliance.

Job Segment: QC, Compliance, Regulatory Affairs, Customer Service, Quality, Legal

📌 Deputy Manager - API (Bavla)
🏢 Dishman Carbogen Amcis
📍 Bavla