13 Job openings found

Job Overview: The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document ...

Duties and Responsibilities : Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy Timely compile materials for license renewals, updates and registrations Maintain regulatory files/database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted ...

Former experience in the following: Working in Medical Device: Initiate, monitor, and verify the effective implementation of the Quality Management System in all areas of company activities Regulatory submissions: Regulations requirements of the ISO 13485; FDA; CE (MDD/MDR) and MEDDEV Composing and maintaining quality manual procedures (i.e., SOP’s), Follow the requirements of GLP/GMP. Internal ...

Experience to prepare and review the documentation required for the ISO 9001:2015, EN ISO 13485: 2016, Quality management System, WHO-GMP, EU MDR 2017/745, IMDR 2017. Knowledge and preparing documents such as Quality Manual, Site Master File, SOP’s, Change Control, Deviation, CAPA, Incident, and Customer complaint, Management Review Meeting, pdate Harmonized Standards, ...

Responsibilities: Corporate Governance: Oversee and ensure compliance with all legal and regulatory requirements. Manage and organize board and committee meetings, including thepreparation of agendas, minutes, and resolutions. Maintain and update statutory books and records. Loan Documentation: Coordinate and manage the end-to-end process of loan documentation. Collaborate with legal and financial ...

Position:        Sr. Executive - Production & Project Location:        Ahmedabad Experience:    8 - 10 years Industries:     Pharma Job Responsibilities:         Operational Management Preparation of URS, ensure equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Oversee operations, ensuring efficient and compliant production. Manage project & production schedules, production planning, ...

The role of a Project Manager in the pharmaceutical industry, particularly in API (Active Pharmaceutical Ingredient) bulk drug manufacturing, is crucial and multifaceted. Here are some key responsibilities: Project Planning and Execution: Define Scope: Clearly define project goals, deliverables, and requirements. Develop Plans: Create detailed project plans, including timelines, milestones, and resource allocation. Monitor ...

1) Ensure that lab cleanliness and safety standards are maintained.2) Develop and qualify new testing methods. 3) Train other analysts to perform laboratory procedures and assays.4) Perform visual inspections of finished products.5) Participate in internal assessments and audits as required. 6) Identify and troubleshoot equipment problems.7) Evaluate new technologies and methods to make recommendations regarding their use.8) Serve as a ...

• Responsible to deliver multiple IT Audit assignments including IT Application and InfrastructureAudits, Application Security Assessments, Vendor Audits, Concurrent Audits, Thematic Assignments,Regulatory submissions etc.• Develop the Risk Based Audit Framework, meeting RBI regulations and adopting ISO 27001Standards.• Manage and liaison with outsourced audit partners with an emphasis on audit time ...

1. NEW PRODUCT DEVELOPMENT RC grades to develop within 3 months time with commercial supply Other MCC combination product range to develop including MCC + Lactose, MCC Spheres,   Technical support including market complain to provide when & where is required Market support and explore to promote MCC, Powdered Cellulose ...