* 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.

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