27 Aug
|
Servocare Lifesciences (P
|
Panchkula
27 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
- Strong Communication, Decision-Making & Problem-Solving Skills
- Proficiency in MS Office and ERP/QMS Software
- Strong leadership and manager
📌 QA Manager (Panchkula)
🏢 Servocare Lifesciences (P
📍 Panchkula