Method Validation, Method Verification, and Method Transfer activities

Lead and coordinate Method Validation, Method Verification, and Method Transfer activities.
Prepare, review, and approve protocols, reports, and technical documents.
Manage and maintain QMS documents including deviations, CAPAs, change controls, OOS/OOT investigations, and risk assessments.
Ensure compliance with cGMP, EU GMP, ALCOA++, Data Integrity, and regulatory requirements.
Review analytical data, chromatograms, calculations, and laboratory records.
Plan and ensure availability of manpower, instruments, standards, reagents, columns, and laboratory resources.
Oversee testing of finished products, stability samples, process validation, in-process, hold-time, and water samples.
Coordinate with R&D, QA, Regulatory Affairs, Production, and SCM for project execution and compliance activities.
Ensure proper operation, calibration, qualification, and maintenance of laboratory instruments and equipment.
Manage LIMS activities and electronic laboratory records.
Provide technical guidance and training to QC analysts.
Support regulatory, customer, and internal audits, ensuring timely closure of observations.
Ensure adherence to laboratory safety, GLP, and hygiene requirements.
Drive continuous improvement initiatives to enhance laboratory efficiency and compliance.
Perform any additional responsibilities assigned by the QC HOD/Designee.