Deputy Manager - API

Dishman Carbogen Amcis Ltd; Bavla; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Dishman Carbogen Amcis Limited in Bavla, Gujarat invites applications for the Deputy Manager - API role. The position focuses on GMP-compliant QA/QC operations, SOP development, and regulatory readiness across analytical labs.

The candidate will review OOS/OOT, deviations, CAPAs, method validations, IQ/OQ/PQ, calibration records, and stability studies, while supporting regulatory affairs, audits, and safety protocols.

Responsibilities

• Preparation, review, issuance, and implementation of SOPs in compliance with regulatory requirements.
• Review, approval, and management of OOS, OOT, Deviations, Incidents, CAPA, and Change Control for 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 QC laboratory instruments.
• Review and approval of AMV protocols and reports.
• Review of IQ, OQ, PQ for QC laboratory equipment.
• Preparation and review of 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 CAPAs are completed within defined timelines.
• Participation in Internal Audits and External Audits (Regulatory, Customer, Certification).
• Providing analytical and documentation support to Regulatory Affairs as required.
• Review and monitoring of Working Standard management and Stability Studies.
• Handling and investigation of customer complaints, deviations, incidents, and CAPAs related to QC activities.
• Ensuring adherence to Safety, Health, and Environment guidelines and PPE usage.
• In the absence of Quality Systems personnel, performing Quality Systems-related activities to ensure continuous compliance.

Job description

Title

Deputy Manager - API

Location

Bavla, Gujarat, IN

Country/Region

IN

State

Guja

City

Bavla

Company

Dishman Carbogen Amcis Limited

Business Unit

General

Custom Field 2: 3061

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.

Job Segment

• QC
• Compliance
• Regulatory Affairs
• Customer Service
• Quality
• Legal