Ashok Modi Email & Phone Number

Ahmedabad . Gujarat

* Successfully achieved first time WHO / ISO accredition for the plant within six months of joining.* Undergone through international audits of Zimbabve, Tanzania, Yemen, Uganda, Nigeria, IDA-Netherlands, Ghana, Ethiopia, Malawi, Malaysia (PIC/S member country), SGS-UK for CE mark etc.* Faced internal / external audits of many big companies outsourcing from the organization.* Significantly assisted the outsourcing companies to formulate products in FFS technology.* Completed ANVISA (Brazil FDA) inspection single-handedly for new plant designed for regulatory market. Credit of getting not a single NCR in five days thorough plant inspection and documents review.* Actively involved in project work for setting up new production lines and gave required GMP requirements as per international standards.* Secured CE Mark Certification (ISO 13485) for one product of EU countries. * Independently leading Project Engineers and Production / Engineering Manager for documentation and validation / qualification activities of new facility / lines, equipments (FFS Machine / Sterilizer etc.), Water System, HVAC Systems; it includes preparing URS, DQ, FAT, SAT, IQ, OQ, PQ, Revalidation etc. as per International latest and future possible requirements.

Ahmedabad Area, India

COMMISSIONING OF NEW CEPHALOSPORIN DRY POWDER INJECTIONS MANUFACTURING FACILITY . AIM TO GET AUDITED BY TGA IN THE YEAR 2014 AND THEN EU , MHRA , MCC AND OTHER AFRICA AND SEA COUNTRIES.OVERALL LOOKING FOR OPERATIONS AND QMS SYSTEM IMPLEMENTATION.

Ahmedabad

* Played a key role in the development of solid / oral liquid dosage forms (mainly psychiatric tablets).* Engaged in the formulation improvement for SR products.* Successfully achieved accreditions of WHO / ISO in just four months of joining and revamping entire documentation with the team work.* Training to staff and workmen on GMP / GLP.

* Significantly engaged in the Sodium Hyaluronate Project.* Indirectly assisted Chairman in Antibiotic sub-committee - IP Committee involving interaction with Working Group / DCGI / IP Sub-Committee Members for many monographs.* Actively involved in USFDA, WHO, MCC audits for API plant and representing the QC / Microbiology aspects.

* Physico-chemical and biological testings of all types of R.M., P.M., F.P. and In-process samples.* Periodic calibration of test equipments internally /externally in coordination with Engineering Dept.* Coordinating the preparation, development and approval of art-works of labels / cartons.* Managing routine maintenance and upkeeping of the analytical equipments on a regular basis as per GLP.

Diploma, Pharmaceutical Q.C. & Q.A.Management (Dpqcqam); Drug Laws;Production Management

Master'S, Pharmaceutical Management (Mdpm)

M.Sc, Bio-Chemistry

B.Sc., Microbiology