Executive Regulatory Documentation

**JOB DESCRIPTION ( Regulatory Documentation)** **.* **Coordination with medical device consultant & will be responsible for creating documentation for certification & Compliance of (MDD)93/42/EEC, ISO 13485:2016, ISO 14971:2012 & Medical device Rules 2017* **.* **Preparation of documentation for submission to INDIAN FDA* **(CDSCO, NEW DELHI) for medical...

**1. Quality Management System (QMS) Implementation** - Develop and implement quality assurance policies, procedures, and SOPs. - Ensure compliance with quality standards such as ISO, GMP, HACCP, or other industry regulations. - Maintain and update quality documentation, including manuals, protocols, and reports. **2. Process Audits & Compliance** - Conduct...

Engineering: Assistant Manager/Senior Executive (Mechanical)Job Description:• Plan, execute, and monitor mechanical engineering activities within the plant.[shine +2]• Oversee installation, commissioning, and preventive maintenance of production equipment (e.g., reactors, mixers, HVAC systems, utilities).[pharmatutor +2]• Supervise equipment breakdown...

v **Preparation of documentation for submission to INDIAN FDA** v **(CDSCO, NEW DELHI) for medical device mfg. certificate approval.** v **FDA / CE / ISO 13485 - Screening of documents, compilation of dossier & drafting of letters and justifications.** v **Internal-External audit compliances** v **Coordination with various consultants for preparation of...

Company DescriptionWe suggest you enter details here.Role DescriptionThis is a full-time on-site role for an Executive located in Paonta Sahib. The Executive will be responsible for overseeing day-to-day operations, coordinating with various departments, ensuring compliance with company policies, and driving strategic initiatives. The Executive will manage...

Job Title: IT ExecutiveIndustry: PharmaceuticalLocation: BhagwanpurReports To: IT Manager / Plant HeadJob Purpose:To manage and support IT systems, infrastructure, and applications within the pharmaceutical manufacturing unit, ensuring data integrity, compliance with regulatory requirements, and smooth functioning of IT operations to support production,...

**Job Title**: Production Chemist **Department**: Production **Location**: Bhagwanpur/ Roorkee. **Reporting to**: Production Manager / Plant Head **Job Purpose**: To oversee and ensure smooth production activities in the pharmaceutical manufacturing unit as per cGMP, SOPs, and regulatory guidelines while maintaining quality, safety, and efficiency...

**1. Quality Inspection & Testing** Conduct inspections of raw materials, in-process production, and finished goods. Perform quality checks using various testing methods and equipment. Ensure compliance with company quality standards and regulatory requirements. **2. Process Monitoring & Compliance** Monitor manufacturing processes to identify quality...

**JOB RESPONSIBILITIES FOR PLANT DRA** **Experience**:2-5 years - Having experience in dossier preparation, compilation & review (CTD & ACTD) for CIS, ASEAN, LATAM, ROW & AFRICAN countries. - Collaboration with internal departments (Production, QA, QC and other concerned departments) to compile quality documents timely, as per country specific...

Job Title: Production ChemistDepartment: ProductionLocation: Bhagwanpur/ Roorkee.Reporting to: Production Manager / Plant HeadJob Purpose:To oversee and ensure smooth production activities in the pharmaceutical manufacturing unit as per cGMP, SOPs, and regulatory guidelines while maintaining quality, safety, and efficiency standards.Key...