Mohan Mc Email & Phone Number

● Preparation of risk assessment by using FMEA tools requirements as per ICH Q9 for introduction of new product into the facility, products and equipment installation into the facility. ● Review & approval of master batch manufacturing record.● Preparation, reviewing & approval of SOP wherein to identify the gap in the GMP system and to meet current regulatory requirement.● Review and approval of Batch Manufacturing Records and Equipment cleaning records.● Experience in preparing and review of process & cleaning validation protocol and reports.● Six Sigma yellow belt certified.● Hands of experience on process improvements by addressing the deficiency.● Hands on experience of handling change control and impact assessments. ● Hands on experience in handling of Deviations, OOS and carrying out investigation report for Non-conformance using fish bone diagram, 5Whys 2H, RCA and FMEA tools.● Hands on experience in handling Customer complaint with respect to quality attributes and physical characteristics complaints of the product and carrying out investigation to identify the root cause.● Corrective Action and Preventive Action for deviations, customer complaints, internal audits, OOS and customer audit observations.● Support for internal audit plans and execution in line with ISO 9001:2015 (Quality management system).● Performing cGMP rounds in manufacturing facility.● Review of process development reports and technology transfer documents.● Review of equipment qualification (URS, DQ, FAT, SAT, IQ, OQ, PQ) document and re-qualification documents.● ISO 14644 cleanrooms design and support for qualifications of air handling units.● Preparation and review of validation master plan.● Hands on experience on computer system validation (Software qualification).● Handling of temperature mapping room/area.● Providing GXP training to all the employees on a scheduled basis. ● Handling GCPD (Global compliance processing and database) activities i.e assessing and providing responses to all the non conformance provided by regulatory and customer auditors at Global scale and GCAR (Global CAPA assessment record) i,e Harmonizing the CAPA arising out of quality event logged throughout the inhouse sites to avoid the recurrence of same. ● Handling of SAP related activities and releasing of batches through SAP.● Preparation of Monthly QMS presentations (QSR and QF data) and weekly tracker (Tracking of quality events) and presenting it to the management.● Handling of vendor qualification.