senior Manager/Manager-Quality Control

Salicylates Chemicals; Hyderabad; On-site; INR 1,500,000 - 2,800,000; Full time

Job summary

Salicylates Chemicals in Hyderabad seeks an experienced QC Lab Manager to oversee laboratory operations. You will supervise all Quality Control activities, ensure timely testing and release of materials, and drive adherence to cGMP, GLP, GDP, and ALCOA+ data integrity.

The role covers instrument management (HPLC/UPLC, GC, ICP-MS, FTIR), stability programs, CAPA, and regulatory/audit support. You will lead a skilled team, ensure safety and housekeeping, and foster continuous quality improvement.

Qualifications

• Minimum 5 years in a managerial or supervisory QC role.
• Experience with regulatory inspections by US FDA, MHRA, EU GMP or WHO GMP.
• Strong knowledge of cGMP, GLP and data integrity (ALCOA+).

Responsibilities

• Plan, organize, and supervise all QC laboratory activities.
• Ensure timely testing and release of materials and samples.
• Monitor turnaround times and ensure compliance with methods and SOPs.
• Review and approve analytical data, CoA, investigations, and deviations.
• Oversee instrument qualification, calibration, and maintenance.
• Lead stability testing programs and CAPA initiatives.
• Prepare for regulatory inspections and audits; drive continuous improvement.
• Mentor QC personnel and ensure safety and housekeeping.

Skills

Chromatography

Spectroscopy

Method validation

Transfer testing

LIMS

Empower

OpenLab

Lab solutions

Trend analysis

Education

Bachelor's/Master's in Chemistry

Tools

HPLC/UPLC

GC/GC-HS

ICP-MS

UV-Vis

FTIR

Karl Fischer Titrator

Analytical Balances

Stability Chambers

Job description

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

• Strong 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.