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GPC Medical Ltd. | ASSISTANT MANAGER
2 weeks ago
Job description
Company Overview:
GPC Medical is a leading Indian manufacturer and supplier of high-quality hospital and medical products, specializing in orthopedic implants and instruments. With nearly a century of experience and compliance with ISO and WHO-GMP standards, we offer a wide range of products, including CE-marked and US FDA 510(k) approved supplies. Our commitment to excellence has established a strong global presence, with our products reaching nearly all European countries and beyond.
Job Summary: We are seeking a detail-oriented and experienced ASSISTANT MANAGER- QA/RA to join our team. This role will involve preparing, reviewing, and implementing all QMS procedures to ensure compliance with regulatory requirements. He/She will also be responsible for preparing technical files, conducting audits, managing risk assessments, and supporting the preparation of registration dossiers.
Key Responsibilities:
QMS Procedures: Prepare, review, and implement all Quality Management System (QMS) procedures to ensure that they meet regulatory standards and internal quality requirements.
Technical File Preparation: Develop and maintain technical files that are accurate, complete, and in compliance with regulatory requirements for products.
Audits: Conduct supplier audits and internal audits, ensuring that all vendors and processes comply with established quality standards.
Risk Management & Documentation: Prepare and review essential risk management documents, including Post-Market Clinical Follow-up (PMCF) reports, Clinical Evaluation Reports (CER), product descriptions, and other related documentation.
Document Control: Maintain and review the master list of documents, records, obsolete lists, CAPA (Corrective and Preventive Actions), and change control documentation to ensure accuracy and consistency.
Regulatory Support: Assist in preparing and compiling dossiers for regulatory registration purposes, ensuring all necessary documentation is included and in compliance with regulatory bodies.