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.

- Robust 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.

📌 Senior Quality Control Manager (Kolhapur)
🏢 Unichem Laboratories
📍 Kolhapur