Role & responsibilities

Laboratory Operations
Plan, organize, and supervise all Quality Control laboratory activities.
Ensure timely testing and release of raw materials, packaging materials, in-process samples, finished products, stability samples, and utility samples.
Monitor laboratory performance to achieve agreed turnaround times (TAT).
Ensure compliance with approved analytical methods, specifications, and SOPs.

Laboratory Compliance
Ensure laboratory operations comply with cGMP, GLP, GDP, and data integrity requirements.
Maintain laboratory documentation in accordance with ALCOA+ principles.
Ensure compliance with regulatory requirements including US FDA, EU GMP, WHO GMP, ICH guidelines, and applicable pharmacopoeias (USP, EP, BP, IP).

Analytical Activities
Review and approve analytical data, calculations, chromatograms, and Certificates of Analysis (CoA).
Review and approve laboratory investigations including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory incidents.
Support analytical method development, validation,



verification, and transfer activities.

Instrument Management
Ensure qualification, calibration, preventive maintenance, and performance verification of laboratory instruments.
Oversee operation and maintenance of analytical instruments such as:
HPLC/UPLC
GC/GC-HS
ICP-MS
UV-Visible Spectrophotometer
FTIR
Karl Fischer Titrator
Analytical Balances
Stability Chambers

Stability Program
Manage the stability testing program in accordance with ICH guidelines.
Review stability protocols, testing schedules, trend analysis, and stability reports.
Ensure timely execution of stability studies and reporting.

Quality Systems
Review and approve SOPs, specifications, protocols, reports, and laboratory procedures.
Implement and monitor Corrective and Preventive Actions (CAPA).
Participate in change control, risk assessment, and continuous improvement initiatives.

Regulatory and

📌 Senior Manager/manager Quality Control Hyderabad
🏢 Salicylates Chemicals
📍 Hyderabad