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 Environment (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.