Senior Quality Control Manager

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.