Quality Assurance Head

4 days ago


Mumbai, Maharashtra, India Anmol Chemicals Private Limited Full time
- To prepare drug dossiers for API/Excipients and finished products for the local/regulated market. Must have working knowledge and be able to handle dossier compilation, submission and follow up independently.- Manage Regulatory Affairs activities. To have good knowledge of global and Indian regulatory requirements. To prepare dossiers for registration of new as well as generic Products.- To give inputs for the preparation and submission of dossiers, MAA (Marketing Authorization Applications) for new drugs. To assure conformity of dossiers to the local statutory requirements.- To assist in preparing dossiers for food ingredients/nutraceutical ingredients/ dietary supplements for the entire world. Be able and willing to read regulations and help with interpretations.-Assist in establishing and tracking effective change control management coming for regulatory review and approval.-Handle/response to the customer and regulatory queries.-Filling and reviewing of customer questionnaire/checklist (VQ)-Excellent attention to detail & accuracy in work-Ability to work well independently as well as in a team environment, effective time management skills and ability to prioritize workload-Training and guidance to subordinates-Preparation of COA, MSDS.-Preparation of STABILITY DATA, TDS, DMF, SDS-Effectively follow the companys standard operating procedures in submissions of documents. -Experience of regulatory Organic & InorganicExperience: 8+ years in regulatory affairs in a pharmaceutical industryEducational Qualification : . ChemistryJob Location Sandhurst Road (5 Minutes Walking distance from Sandhurst Road railway station.Salary Maximum 30 percent Hike over current salary
  • Experience3 - 8 Years
  • No. of Openings25
  • EducationB.Sc, M.Sc
  • RoleQuality Assurance Head
  • Industry TypeManufacturing / Production / Quality
  • Gender[ Male / Female ]
  • Job CountryIndia
  • Job TypeWork from Office

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