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