Senior Executive

Cadila Pharmaceuticals Limited; Mumbai; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Mumbai seeks a QC professional to plan, supervise, and execute 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.

Responsibilities include reviewing data, COAs, and lab records; coordinating instrument qualification and maintenance; supporting OOS/OOT

Qualifications

• 5–8 years of relevant QC experience in pharmaceutical manufacturing or API labs.
• Proficient in HPLC/GC, data analysis, and lab documentation.
• Experience with ALCOA+ data integrity and regulatory compliance (cGMP/GLP).
• Knowledge of validation/verification, deviations, CAPA, and OOS/OOT investigations.

Responsibilities

• Plan and supervise routine QC testing of raw materials, intermediates, APIs, solvents, and finished products.
• Review analytical data, calculations, chromatograms, spectra, and laboratory records.
• Ensure testing is performed according to approved specifications and SOPs.
• Review and approve analytical worksheets, test reports, COAs, and documentation.
• Investigate and support OOS/OOT deviations and laboratory incidents.
• Coordinate instrument qualification, calibration, and preventive maintenance.
• Review and execute analytical method validation/verification/transfer activities.
• Manage stability study testing and sample management.

Skills

HPLC

GC

Documentation

Data integrity

Troubleshooting

Cross-functional coordination

LIMS

Education

M.Sc. Chemistry / M.Pharm / B.Pharm or equivalent

Tools

Empower

LIMS

Job description

Job Description

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.

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.

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

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.

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

Audit/inspection readiness