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

Solid 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 (India)
🏢 Salicylates Chemicals
📍 India