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,

📌 Senior Executive (Mumbai)
🏢 CPL Pharmaceuticals Private
📍 Mumbai