Arun Kumar P

Experience

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  Nandu Chemical Industries

  Aug 2005 - now

  QA/QC Manager

  Having 18 years of experience in Manufacturing Active Pharmaceuticals Ingredients(API), Production, QA & QC● Preparation of production facilities related SOPs, Batch manufacturing records, Batch packing ● Records and training of SOPs to Concern operators. ● Testing of all API products as per monographs like BP, IP,EP, USP and FCC. ● Participation in carrying out in Process Validation, Cleaning validation and Equipment Qualification & in internal quality audit. ● Coordination with Quality assurance dept for preparation & review of validation. Protocols, Qualification protocols & production SOPs. ● Inspection of new tooling’s, checking & maintaining of punch utilisation record. ● Addressing market complaints and development of corrective & preventive. Propositions to avoid recurrence of the same. ● Training of concern documents for fresher and preparation of training records. ● Checking and maintaining monthly maintenance records of machines. ● Calibration of all measuring equipments in the production area. ● Batch Review & Yield reconciliation. ● Ensure healthy work environment & discipline amongst workers.*Audit Exposures:● GMP Audit● ISO 14001 Audit● OSHAS 180001Audit● Party Audit like Korea FDA, South Africa, Johnson & Johnson, Baxter, Freseneus Kabi ,WHO audit, Nestle , Serum Institute, Abbot Show less