American Society for Quality Certified Manager of Quality/ Organizational Excellence (ASQ-CMQ/OE), Certified Pharmaceutical GMP Professional (ASQ-CPGP) & Quality Auditor (ASQ-CQA):
- Having 15+ years of versatile industrial experience in QA and Production functions at API/ Formulation facilities (approved by various regulatory agencies USFDA, TGA, MHRA, WHO etc.) of top pharma companies in India such as Aurobindo Pharma Ltd., Mylan Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Ipca Laboratories Ltd. and Abbott Healthcare Pvt. Ltd.
- Having experience in complying various cGMP regulations/ standards of 21 CFR, ICH, WHO guidelines, EMA regulations, PIC/S, EU-GMP, Canada GMP, TGA GMP, ISO 9001, ISO14001 and ISO 19011.
- Having experience in designing various types of quality management system documents such as quality manual, SOPs, work instructions, site master file, corporate/ global guidance documents, employee training program, vendor management program, batch records, validation master plan, qualification documents and process/ cleaning validation documents.
- Having experience in handling Regulatory audits of USFDA, MHRA, WHO, TGA, KFDA and PMDA.
- Having experience in dealing with quality system elements such as personnel training, quality risk management, deviation, change control, internal audits, complaints, recall & CAPA.
- Having experience in designing and implementing software applications such as eQMS, audit tracker, GMP forum etc. with the help of IT tools.
- Having Training and certification on 'Cleaning Validation' by Destin A. Leblanc.
- Having Training on Culture of Quality and Data Integrity Assurance'by Dr. Ajaz S Hussain.
- Having proven expertise in dealing with large geographically and culturally diverse teams.
- Being open minded, fast learner, quick thinker & smart in using innovative techniques while performing duties to provide solutions which are simple, user- friendly & regulatory compliant.
Currently working as Chief Manager- Quality Assurance (Corporate) for Abbott Healthcare Pvt. Ltd,, Mumbai, India.