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 Audit Support

- Prepare the QC laboratory for regulatory inspections and customer audits.
- Participate in internal, customer, and regulatory audits.
- Ensure timely closure of audit observations.

Team Management

- Lead, mentor, and develop QC personnel.
- Allocate work and monitor staff performance.
- Identify training needs and ensure competency development.
- Foster a culture of quality, safety, and continuous improvement.

Safety and Housekeeping

- Ensure compliance with laboratory safety procedures and environmental requirements.
- Promote safe handling, storage, and disposal of chemicals and laboratory waste.
- Maintain laboratory cleanliness and organization.

Preferred candidate profile

- Minimum 5 years of experience in a Managerial or supervisory role.
- Experience with regulatory inspections by US FDA, MHRA, EU, WHO, or other international agencies is preferred.

Technical Skills

- Robust knowledge of chromatographic and spectroscopic techniques.
- Expertise in analytical method validation and transfer.
- Knowledge of laboratory investigations (OOS, OOT, deviations).
- Familiarity with LIMS, CDS (Empower, OpenLab, LabSolutions), and Microsoft Office.
- Knowledge of statistical tools and trend analysis.
- Those Interested can share their Cv's on [email protected]

📌 senior Manager/Manager-Quality Control (Hyderabad)
🏢 Salicylates Chemicals
📍 Hyderabad