Senior Quality Control Manager

Unichem Laboratories; Kolhapur District; On-site; INR 600,000 - 900,000; Full time

Job summary

Unichem Laboratories in India is seeking a QC professional to ensure timely analysis of raw materials, intermediates, finished products, and stability samples against specifications. The role involves investigating deviations, leading CAPA actions, and ensuring cGMP and GLP compliance with proper documentation.

The incumbent will oversee method validation/verification, transfer activities, and updates to global pharmacopoeias, while maintaining data integrity and efficient cross-functional

Qualifications

• Experience with regulatory inspections such as USFDA, MHRA, EMA, and TGA.
• Auditing of finished-dose units, API manufacturers, and vendors involved in intermediates/KSMS.
• API manufacturing experience would be preferred.
• Strong understanding of QC department duties and regulatory compliance.

Responsibilities

• Ensure timely analysis of materials, intermediates, finished products, and stability samples against specifications.
• Investigate events, deviations, OOS/OOT with root-cause analysis and CAPA documentation.
• Lead audit responses and self-inspections; close CAPAs and observations.
• Ensure compliance with cGMP, GLP, data integrity; timely online documentation.
• Oversee transfers, method validation/verification; implement pharmacopoeia updates.
• Review quality trends; ensure CAPA-driven improvements in QC.
• Sampling, analysis, report verification, and release/rejection of water samples.
• Ensure GLP compliance via instrument calibration, standardization, logbooks, and preventive maintenance.
• Qualify new instruments via change control and risk assessment.
• Ensure SAP, LIMS, chromatography systems operate per procedures and data integrity rules.
• Maintain availability of chemicals, glassware, instruments, and prepare QC budget.
• Review work allocation, production plans, and staffing; oversee recruitment.
• Drive GMP/GLP/Safety training; coordinate cross-functional QC meetings.

Skills

Root-cause analysis

CAPA management

Regulatory inspections

GMP/GLP

Documentation

Quality systems

Tools

SAP

LIMS

Chromatography

Job description

Role & responsibilities

RESPONSIBILITIES

• Ensure timely analysis of raw materials, packaging materials, solvents, in-process materials, intermediates, finished products, and stability/validation samples against approved specifications.
• Ensure timely investigation of events, deviations, OOS, OOT results, and other non-conformances using root-cause analysis, with proper documentation, scientific rationale, and CAPA implementation.
• Lead audit responses, conduct self-inspections, assess the effectiveness of the Quality Management System, and ensure timely closure of observations and CAPAs.
• Ensure compliance with cGMP, GLP, data integrity requirements, and applicable regulatory guidelines, including accurate and timely online documentation of all relevant activities.
• Oversee technology transfers, analytical method validation and verification, and the effective implementation of updates to relevant global pharmacopoeias.
• Ensure required quality and laboratory trends are performed, reviewed, and followed by appropriate CAPA implementation.
• Ensure proper sampling, analysis, report verification, and release or rejection of potable water, purified water, and rinse water samples.
• Ensure GLP compliance through timely instrument calibration and verification, volumetric solution standardization, logbook completion, daily monitoring, and preventive maintenance.
• Qualify new instruments through approved change control and risk assessment procedures.
• Ensure SAP, LIMS, chromatography, and other laboratory software are operated in compliance with approved procedures, GAMP 5 requirements, data integrity principles, and role-based access controls.
• Ensure adequate availability of chemicals, glassware, instruments, equipment, laboratory standards, reagents, and other essential materials, and prepare the annual capital expenditure budget for the Quality Control Department.
• Review work allocation based on production plans, priorities, and laboratory requirements, and oversee recruitment to maintain optimal staffing levels.
• Drive training programs on GMP, GLP, safety, hygiene, data integrity, and laboratory applications.
• Coordinate with internal stakeholders through regular cross-functional and corporate meetings to ensure effective communication and timely resolution of Quality Control matters.

Desired Skills

• Should have strong experience in handling regulatory inspections such as USFDA, MHRA, EMA, and TGA.
• Should have strong experience in auditing finished-dose formulation units, API manufacturers, and intermediate/KSM vendors.
• Experience in an API manufacturing unit would be preferred.
• Strong experience and knowledge of activities and duties of Quality Control department in a pharmaceutical organization
• Knowledge of compliance must be strong.
• Proactive approach to queries, with strong problem-solving, decision-making, and communication skills.
• Ability to manage multiple stakeholders, lead teams, and work effectively across functions.
• High standards of business ethics, integrity, confidentiality, attention to detail, and compliance.
• Should be willing to work in dynamic environment.