Sr. Executive / Assistant Manager - QMS / Investigation

Position :

Location :

Qualifications :

Experience :

Reporting to :

Job Summary :

Key Responsibilities:

•To establish and follow the process to assure that investigations at the site are aligned with respective site SOPs and to evaluate the adequacy of the scientific justification, root cause determination, and CAPAs proposed in response to investigation findings.

•To monitor compliance with data integrity standards at the manufacturing site by performing regular inspections focused on data integrity checks, challenging the site procedures for data integrity compliance, random review of batch manufacturing records, analytical records, paper-based raw data, electronic data & audit trails.

•To provide support for site readiness for regulatory inspections by technical & quality inputs through regular visits and checks.

•Handling of events and change controls in KabiTrack-related FKOL Kalyani.

•Assessment of change controls and review of documents in document management system, related to FKOL Kalyani.

•Proficient in conducting/Reviewing/leading team responsible for Audit trail review, Preventive maintenance, performance monitoring, inventory management, user management, Backup & restoration etc for GxP systems.

•Implement and maintain data integrity measures, focusing on ALCOA+ attributes. Define policies to improve data security, system security to enhance compliance.

•Proficient in drafting, review of GxP document as part of ongoing Quality management systems activities as per assigned role.

Skills:

oStrong understanding of USFDA, EMA, MHRA, and other regulatory requirements. oFamiliar with ICH, 21CFR Part 210/211/11, EU-GMP, PIC/S GMP and other regulatory requirements. oGood Knowledge of Quality Management Systems and current quality trends oGood exposure in QA functions of production units

Strengths:

oProven regulatory compliance expertise. oEffective communication, with strong analytical, interpersonal, and problem-solving skills. Takes initiatives, ownership, and responsibility of assigned activities. oGoal oriented, Self-driven with strong commitment to work. oStrong report writing, reading, presentation, and investigational skills.