Executive Regulatory Documentation

**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...

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...

**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...

**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...

Analysis of samples by chemical method and online reporting of in process and intermediate samples and analysis of in process validation samples. Analysis of samples by methods using HPLC Agilent. Thorough knowledge on handling Validation & calibration of HPLC. Knowledge on handling of OOS, Deviations, Incidents. Should have Knowledge on Wet...

Walter Bushnell is hiringPosition: Production Officer / Executive / Asst ManagerDepartment: ProductionExperience: 5-15 yearsLocation: Roorkee (New Plant)Qualification: B.Pharm / M.Pharm / B.ScKey Responsibilities:Oversee end-to-end production activities for the new pharmaceutical manufacturing plant.Involve in new project setup equipment installation,...

Company DescriptionBadrivas Biotech Private Limited is dedicated to delivering high-quality healthcare solutions that positively impact lives. We specialize in manufacturing and distributing trusted pharmaceutical products with a strong emphasis on safety, efficacy, and excellence. Our teams in Production, Quality Assurance, and Quality Control uphold the...

Company DescriptionBadrivas Biotech Private Limited is dedicated to delivering high-quality healthcare solutions that positively impact lives. We specialize in manufacturing and distributing trusted pharmaceutical products with a strong emphasis on safety, efficacy, and excellence. Our teams in Production, Quality Assurance, and Quality Control uphold the...

Company DescriptionBadrivas Biotech Private Limited is dedicated to delivering high-quality healthcare solutions that positively impact lives. We specialize in manufacturing and distributing trusted pharmaceutical products with a strong emphasis on safety, efficacy, and excellence. Our teams in Production, Quality Assurance, and Quality Control uphold the...

Company DescriptionBadrivas Biotech Private Limited is dedicated to delivering high-quality healthcare solutions that positively impact lives. We specialize in manufacturing and distributing trusted pharmaceutical products with a strong emphasis on safety, efficacy, and excellence. Our teams in Production, Quality Assurance, and Quality Control uphold the...