Senior Executive

5–8 years of relevant experience in Quality Control, preferably in API/pharmaceutical manufacturing.

Job Overview

Responsible for planning, supervising, and executing quality-control activities for raw materials, intermediates, finished APIs, in-process samples, and stability samples. The role ensures laboratory activities comply with cGMP, GLP, SOPs, data-integrity requirements, and applicable regulatory standards.

Key Responsibilities

Plan and supervise routine QC testing of raw materials, intermediates, APIs, solvents, and finished products.

Perform/review Analysis Using Techniques Such As

HPLC

GC

UV-Visible spectroscopy

FTIR

Karl Fischer

pH / conductivity

Titration and wet-chemistry methods

Other applicable analytical techniques

Review analytical data, calculations, chromatograms, spectra, and laboratory records.

Ensure testing is performed according to approved specifications, STPs, analytical methods, and SOPs.

Review and approve analytical worksheets, test reports, COAs, and laboratory documentation as per authorization.

Investigate and support OOS, OOT, deviations, and laboratory incidents.

Participate in root-cause investigations and implementation of CAPA.

Ensure proper handling, calibration, and maintenance of laboratory instruments.

Coordinate instrument qualification, calibration, and preventive maintenance activities.

Review and execute analytical method validation/verification/transfer activities.

Manage stability study testing and ensure samples are analyzed according to approved protocols and schedules.

Ensure proper sample management, storage, retention, and disposal.

Maintain laboratory housekeeping and ensure compliance with GLP/GMP requirements.

Ensure adherence to ALCOA+ data-integrity principles and electronic data controls.

Train QC analysts on analytical procedures, instruments, SOPs, GMP, and safety.

Coordinate with Production, QA, R&D, and other departments for analytical requirements.

Support internal, customer, regulatory, and external audits.

Prepare and provide QC documentation and analytical data during inspections and audits.

Identify opportunities for improving laboratory efficiency, analytical reliability, and turnaround time.

Regulatory / GMP Knowledge

Strong knowledge of cGMP and GLP requirements.

Understanding of ICH guidelines, particularly relevant analytical and stability requirements.

Knowledge of ALCOA+ data integrity principles.

Familiarity with OOS/OOT investigation procedures.

Understanding of deviation, CAPA, change control, and laboratory incident management.

Knowledge of analytical method validation and verification.

Experience With Audit And Regulatory Inspection Requirements.

Technical Skills

Hands-on experience with HPLC and GC.

Knowledge of chromatographic data systems such as Empower or equivalent.

Experience with analytical instruments and laboratory software.

Good understanding of analytical method troubleshooting.

Knowledge of laboratory investigations and root-cause analysis.

Working knowledge of LIMS is an advantage.

Good documentation and report-writing skills.

Qualification

M.Sc. Chemistry / M.Pharm / B.Pharm / equivalent qualification from a recognized institution.

Key Competencies

Analytical testing and troubleshooting

HPLC/GC expertise

Data review

OOS/OOT investigation

GMP/GLP compliance

Data integrity

Team supervision

Documentation

Problem-solving

Cross-functional coordination

Key Performance Indicators (KPIs)

Testing turnaround time

Analytical accuracy and reliability

OOS/OOT investigation effectiveness

Compliance with GMP/GLP requirements

Data-integrity compliance

On-time stability testing

Instrument calibration/qualification compliance

Audit/inspection readiness