Jimmy Karihalu Email & Phone Number

India

To ensure full implementation of Quality Management System (QMS) like Internal audit, External audits , Vendors/Supplier performance , Corrective and Preventive Actions, Non-Conforming Material Report, Post Market Risk Assessment, First pass yield, Complaints, Change control at site. To ensure maintenance of all Quality metrics as per the target set by team.Maintain Global regulatory quality system approval status ( MDSAP,EUMDR & ISO 13485:2016)

Haridwar Area, India

Was overviewing facilities of Akums pharmaceuticals limited that includes Dosage form (Tablets, Capsule (Powders& Pellets), Beta lactams, Neutraceutical products.• Approval, authorization and to ensure effective implementation of various master documentsin Plant like Quality manual, SMF,VMP, SOP’s, Protocols, MFR’s, MPR’s, BMR, BPR’s etc.• To lead all Regulatory and Customer Audits.• To lead preparation, Review and final approval of response to be provided to either Regulatory authorization or customer against Audit findings/Observations.• To approve change control, deviations, incidents, control of non-conforming materials/products.• To approve analytical method validation, analytical method verification, analytical method transfer, OOS, OOT, etc.• To ensure timely completion of all CAPA action items.• To lead the site for all investigations and to establish RCA related to market complaint, market return and product recall.• To approve risk assessment, APQR/APR, Validation, Calibration, Qualification Documents.• To approve stability reports, stability Data, Stability summary and trends.• To ensure that in-process controls are performed as per process during manufacturing operations.• To ensure proper Documentation control, distribution, archival and destruction system as per the requirement of QMS.• To present status of QMS (internal audit/ self inspection, external Audit compliances, corrective action preventive action (CAPA), Environment and safety incidents, customer complaints, deviation, change in the organization, improvement done and requirements for Quality up gradation etc. to management during Quality Management Review (QMR) Corporate Quality Review QRA).• Maintenance of all documentation in accordance with QMS.• To impart GMP, GDP, GLP, SOP’s, behavioral, motivational and other related training (class room and shop floor).• To ensure timely submission of documents to customers and Drug Regulatory affair (DRA).

Bhiwadi

• Leading the implementation of quality across Raw Materials, Work In Progress, Finished Goods across various functional Departments. • Conducting regular Internal Audits, Root Cause Analysis, Troubleshooting and reviews to ensure adherence to highest standards. • Overseeing implementation of quality tools, to streamline and standardize work flow. • Training and guiding teams on towards identifying factors critical to quality, reducing process variation, improving capabilities & increasing stability. • Review of Equipment qualification documents.• Developing protocols for Process/ Cleaning Validation, and Validation Reports.• Supporting Projects for upgrading facility through facility qualification & Building management system• Ensure compliance to Quality system. Monitor the Quality system efficacy through audits • and CAPA (Corrective and Preventive Action) analysis. • To sign technical agreement with all manufacturing suppliers.• Reviewing the operational practices, identifying the areas of obstruction and advising on system and process changes for qualitative improvement and energy conservation. • Review and up gradation of Site master file, Validation master plan, Quality manual.• Review of documents like SOPs, specifications and revised update as per the requirements of cGMP/ ICH guidelines/Pharmacopeias. • Handling of Market complaints & their compliance.• Review of stability documents of Quality control.• Conduct of OOS investigation.• Set up a system for validation of new products, new processes and new material and ensure that validation protocols are rightly approved and are complied with.• Organizing timely Internal Audits. Ensure follow-up by coordinating and implementing CAPA in a timely manner. Propose and implement systemic corrective actions.• Provide positive support to Materials function in developing new and existing vendors and improving their performance.

New Delhi Area, India

• Water system validation & HVAC Validation.• cGMP & SOP based training to employees and maintaining records as per training records. Ensure that Quality training is imparted to staff & disseminate the Quality Policy among all. • Review of documents like SOPs, specifications and revised update as per the requirements of cGMP/ ICH guidelines/Pharmacopeias. • Review of Equipment qualification documents.• Protocols preparations for Process/ Cleaning Validation, and Validation Reports.• Set up a system for validation of new products, new processes and new material and ensure that validation protocols are rightly approved and are complied with.• Experience of successfully handled inspections / audits by international regulatory agencies.• Provide positive support to Materials function in developing new and existing vendors and improving their performance.• Support to Mfg, Warehouse, QC, QA, HR, for the preparation of Audits.• Monitoring & updating systems wrt current requirements.• Supporting Projects for upgrading facility through facility qualification & Building management system.• Improve product and process quality, reduce costs and increase productivity.• Responsible for daily inspection of the site for GMP compliance to international standards and take immediate corrective actions. Devise effective follow up program to improve the systems and confirm GMP compliance.• Faced Ukraine Audit successfully.

New Delhi Area, India

Was responsible for Preparation and execution of Process Validation Protocols. • To perform Audit of Contract manufacturing facilities for GMP Compliance. • Periodic validation schedule preparation and execution of Own-manufacturing and Contract-manufacturing sites.• Preparation and execution of Curriculum and Module based Training Program of CQA subordinates and CM location personnel. • Handling of Corporate Quality Change Control issues.• Investigation of Market Complaints and Out-of-specification.• Co-ordination with contract manufacturing sites regarding production issues.• Co-ordination with Regulatory Affair department for preparing product dossiers for different countries.• Review and approval of Documents received from R&D Department.• Preparation and implementation of corporate SOPs and Master Plans.• Preparation and review of Monthly / Quarterly / Yearly CQA reports.

New Delhi Area, India

• Was Involved in the planning of the production functions of the company which comprises of various planning, co-ordination and controlling activities of works.• Supervision of manufacturing, filling, packing of various dosage forms.( Tablets, Capsules, Liquid, Ointment ,Gel and dry powder.• Responsible for continuous improvement in productivity with better utilization of resources like men, machine & material as well as changes in procedures.• Maintaining all the documents like Batch Manufacturing record, Technical direction and Packaging records.• Maintaining good house keeping as per c G.M.P.• Procurement of purified water and its purification through R.O. System and validation of water system.• Work allotment to workmen as per their skills.• Preparing standard operating procedures for all the equipments and other procedures and implementation of standard operating procedures• Calibration of all the equipments in-house as well as from outside agencies.• Co-ordination with other department like Quality Control, Quality Assurance R&D, Raw material store, Packing material store, Finished good store and Procurement.• Meeting tight production schedules within specified period of time with good productivity.• Responsible for manpower productivity improvement by continuously motivating the workers by job rotation and control of process rejections and training to workmen resulting in improved productivity and smooth functioning of production.

New Delhi Area, India

Worked as R&D Chemist with Dee Pharma Ltd for one and half year.

B. Pharma, Pharmacy

12Th, Chemistry,Physics,Biology