Ashok Kumar Email & Phone Number

Hyderabad Area, India

Currently associated with Nosch Labs Pvt.Ltd [Part of Chemo group], Hyderabad as a Sr.Manager –QALed the quality functions of Nosch Labs Pvt.Ltd and reported to VP-Corporate QA/RA.Handled several customer audits as well as one regulatory audit [USFDA] during my tenure Effectively performed leader ship roles for smooth running of quality system as per company core policiesProficient in assessing existing systems and accordingly designing and implementing measures… Show more Currently associated with Nosch Labs Pvt.Ltd [Part of Chemo group], Hyderabad as a Sr.Manager –QALed the quality functions of Nosch Labs Pvt.Ltd and reported to VP-Corporate QA/RA.Handled several customer audits as well as one regulatory audit [USFDA] during my tenure Effectively performed leader ship roles for smooth running of quality system as per company core policiesProficient in assessing existing systems and accordingly designing and implementing measures aimed to enhancingquality management systemsSkillful and coordinating with subordinates and mapping their competencies, utilization of their resourcesPro active attitude, excellent inter personnel skills with proven abilities in implementation of quality management systems.Specialties:Quality systems compliance Show less

Hyderabad Area, India

Developing and establishing Quality Assurance systems and procedures to meet all international / regulatory requirements. Identification of gaps in documentation system, guidance to QA in designing documentation. To ensure manufacturing practices are followed as per cGMP and ICH guidelines by inspecting manufacturing areas and effective internal audits. Driving Quality Management concept and Good Laboratory practices. Actively participate in Management reviews and discussions.

Significant contribution supplied for the compliance of key quality systems i.e. change controls management, deviations & OOS investigations, customer complaints investigation,validations and qualifications etc...Played a vital role as a coordinator for the fulfillment of regulatory/customer requirements and queriesHarmonized several core SOPs to in-line with regulatory requirement and updated the procedures/formats according to audit NCs complianceParticipated to… Show more Significant contribution supplied for the compliance of key quality systems i.e. change controls management, deviations & OOS investigations, customer complaints investigation,validations and qualifications etc...Played a vital role as a coordinator for the fulfillment of regulatory/customer requirements and queriesHarmonized several core SOPs to in-line with regulatory requirement and updated the procedures/formats according to audit NCs complianceParticipated to several regulatory [USFDA,WHO, PMDA, AGES & EDQM] and customer audits as a audit team memberMaintained on-line systems and documentation at plant level with continuous monitoring Show less

Hyderabad Area, India

Preparation and review of SOP's.Preparation and review of Batch Manufacturing Records.Preparation and review of Trend analysis reports.Preparation and review of APQR's.Conduct online audits/monitoring.Review of Qualification or Validation protocols and reports.

Bachelor'S Degree, Bsc.

Education record