14 Job openings found

Job Summary: The Manager – Global Statutory Compliance will be responsible for ensuring that Alfa Gate’s dental implants meet stringent regulatory compliance standards required for market access across international jurisdictions, including India (CDSCO), USA (USFDA), China (NMPA), Brazil (ANVISA), Europe (EMA), and UAE (Ministry of Health and Prevention - MOHAP). The position ...

JOB ROLE International Regulatory Role JOB CODE TBD DEPARTMENT Regulatory Affairs JOB LOCATION Gurgaon BAND LEVEL T DESIGNATION Deputy Manager JOB PURPOSE The incumbent shall be responsible for Registration of agrochemicals in Latin America or any other internation country / territory as per regulatory framework.   RELATIONSHIP & REPORTING STRUCTURE DIRECT SUPERVISOR / MANAGER R&D Head SKIP LEVEL MANAGER JMD NO. OF DIRECT REPORTS NA DOTTED LINE MANAGER NA   AREAS OF ...

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, ...

Position:          Asst. Manager - Packing  Location:         Bhopal Experience:      8 - 10 Years Industries:       Pharma Responsibilities: Operational Management: Oversee packing operations, ensuring efficient and compliant production. Manage packing schedules, production planning, and resource allocation. Monitor and optimize packing line performance, productivity, and quality. Quality Assurance: Ensure compliance with GMP, regulatory requirements, and ...

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 ...