28 Aug
|
Servocare Lifesciences (P
|
Panchkula
28 Aug
Servocare Lifesciences (P
Panchkula
Key Responsibilities
Lead and manage the complete Quality Assurance function across the organization.
Develop, implement, and continuously improve the Quality Management System (QMS).
Ensure compliance with WHO-GMP, Schedule M, ISO, USFDA/EU-GMP, and applicable regulatory requirements.
Oversee internal audits, external audits, customer audits, and regulatory inspections.
Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, Specifications, Validation Protocols, and Quality Documents.
Manage Change Control, CAPA, Deviations, OOS investigations, and risk assessments.
Oversee qualification and validation activities, including equipment, process, cleaning, and analytical method validation.
Review and authorize product release in accordance with quality standards.
Lead vendor qualification, supplier audits, and quality agreements.
Ensure compliance with Data Integrity (ALCOA+) principles and documentation practices.
Coordinate with Production, QC, Regulatory Affairs, R&D;, Purchase, and Warehouse for effective quality management.
Drive continuous improvement initiatives and promote a solid quality culture across the organization.
Lead, mentor, and develop the Quality Assurance team to achieve departmental objectives.
Required Skills:
Complete Quality Management System (QMS) Implementation & Maintenance
Regulatory Compliance & Documentation
Internal & External Audit Management
Validation Oversight (Process, Cleaning, Equipment & Analytical Methods)
Risk Management & Quality Risk Assessment
Vendor Qualification & Supplier Audits
Change Control Management
CAPA & Deviation Management
Product Release Authorization
Regulatory Inspection Management
Data Integrity Governance (ALCOA+)
Strategic Quality Planning
Team Leadership & Performance Management
Robust Communication, Decision-Making & Problem-Solving Skills
Proficiency in MS Office and ERP/QMS Software
Solid leadership and manager
📌 Qa Manager Panchkula
🏢 Servocare Lifesciences (P
📍 Panchkula