Regulatory Affairs Job Vacancies in Palghar

Roles and Responsibilities :Regulatory/ DMFAsking for necessary technical inputs from various departments in the Factories and doing its assessment.To give the necessary technical inputs required by the respective government departments (FDA, CDSCO ) under the guidance of the Head RegulatoryCompilation, review and submission of DMF (Drug master file) to Regulatory & ROW markets as per the given guidelines.To keep DMF files active as per the agency requirements.Revision/Renewal of CEP.Compilation & submission of Applicants part DMF (Drug master file) & QOS for customers.Compilation & Submission of RP DMF for authorities.Submissions of DMF Annual report to USFDASubmissions of DMF amendments to USFDAReply to the queries raised by respective authoritiesCustomer ServicingResponsible to address different questions and queries (technical) in the given time frame for customersTo get the necessary information from QA, QC for compilation and onward submission to regulatory authorities and customers as response to their queriesTo evaluate the technical agreements /CDA to be signed with the customers as on basis.Review of vendor questionnaire within the required timeframe along with supporting documents to customers and maintaining the record for the same.Preparation of the certificate of suitability for various customersPreparation/review of different kinds of declarations as per customer requirementsReview of change control, customer notification/intimationKeeping the track of customer notification/Intimation and response to the various queries raised by various customers & Log Maintenance Preparation of LOAs

Devise procedures to inspect and report quality issues Monitor all operations that affect quality Supervise and guide inspectors, technicians and other staff Assure the reliability and consistency of production by checking processes and final output Appraise customers requirements and make sure they are satisfied Report all malfunctions to production executives to ensure immediate action Facilitate proactive solutions by collecting and analyzing quality data Review current standards and policies Keep records of quality reports, statistical reviews, relevant documentation and perform statistical analysis Communicate with external quality assurance officers during on-site inspections Devise and review specifications for products or processes Ensure adherence to health and safety guidelines as well as legal obligations Oversee all product development procedures to identify deviations from quality standards Inspect final output and compare properties to requirements Approve the right products or reject defectives Keep accurate documentation and Solicit feedback from customers to assess whether their requirements are met Submit detailed reports to appropriate executives Be on the lookout for opportunities for improvement and develop new efficient procedures WHO GMP requirement, complied all the non conconformities. Carried out all for ISO & WHO GMP, Handle Safety audit.KEY REPONSIBILITES Review & Preparations of Quality Management system documents. Review, preparation & Implementation of SOPsQUALIFICATION & VALIDATION Preparations & execution of qualification and validation of various manufacturing & packing equipments.PROCESS VALIDATION Preparations & Execution of process validation activity.