A keen planner with proficiency in enhancing the Quality standards and related operations like validations, technical transfer, analytical method transfers, stability studies, qualifications and proficiency in implementation of the same.• Proficient in managing documentation to ensure accuracy as per regulatory requirements. Experience in managing self-inspections and internal audits as per ICH Q7. cGMP understanding and systematic implementation of quality systems based on ICH and other regulatory guidelines through continual training of personnel and periodic reviews.• Experience in evaluating vendors through desktop reviews and site visits.• Experience in handling major audits like USFDA, EUGMP, ANVISA, TGA and KFDA along with customer audits.• Experience in finalizing quality agreements, customer questionnaires, compilation of audit responses and monitoring their timely execution.• Managing product certification activities.• A highly motivated Business Intelligence professional and people manager with positive attitude and good communication skills.Specialties: Audit compliance, Quality management system, Quality Assurance, training and development.To ensure continual training of the personnel pertaining to quality systems, procedures and amendments.•Assessing and approving vendors through vendor audit.• Responsible for the decision making process in matters that affect the quality of products including development, production, laboratory, storage, distribution, vendors and third party contractors.• To ensure self-inspections and quality audit on regular basis to appraise the effectiveness andapplicability of the quality management system.• To ensure that the investigations of deviations, discrepancies and out of specifications are carried out effectively as per Quality Assurance system.

Management staff in Cipla Quality Control Formulation