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.
Job Segment: QC, Compliance, Risk Management, Quality, Legal, Customer Service, Finance
