QA-QMS, CAPA, OOS, APQR, IPQA, Audit and compliance

QMS lead, audit and compliance, Investigation, training, document management, CAPA.

Skills:•QMS •OOS • BMR• APQR• Batch Record Review •Trackwise •Microsoft Office •SAPDetailed: • Establishment of procedures for QMS and QA Documentation.• Handling of QMS tools i.e. Change Control, Deviation, CAPA, OOS ( established till now in plant)• Preparation and Review of Standard Operating Procedure related to QA department.• To provide the Training of QMS and QA related SOPs (i.e. Change control, CAPA, Deviation, GDP, Documentation management, Investigation and root cause… Show more Skills:•QMS •OOS • BMR• APQR• Batch Record Review •Trackwise •Microsoft Office •SAPDetailed: • Establishment of procedures for QMS and QA Documentation.• Handling of QMS tools i.e. Change Control, Deviation, CAPA, OOS ( established till now in plant)• Preparation and Review of Standard Operating Procedure related to QA department.• To provide the Training of QMS and QA related SOPs (i.e. Change control, CAPA, Deviation, GDP, Documentation management, Investigation and root cause analysis) • Preparation and review of Site Master file.• Handling Vendor qualification program (Vendor Audit), Service provider, contract testing lab qualification. (To perform audit, Questionnaire review, Compliance verification, Annual Assessment)• Review and arrangement of all documents before audit as per Audit Agenda and to ensure the Audit compliance status.• Review of lab incident and deviation investigation report.• Review and evaluation of Change controls, follow up on actions related to change control implementation to ensure timely closure.• Co-ordination with the SAP/IT team for the development of SAP module related to QA (SOP and training management, Format management, Change control, Deviation, OOS, Lab incidence, CAPA)• Supervise: Issuance, retrieval and destruction of Documents, SOP, Protocols, logbook. • Co-ordinate with the R & D and project management team for documentation movement.• Co-ordinate with other department for the system based SOPs implementation.• Review of Qualification Documents (DQ,IQ,OQ,PQ of HVAC, Machine/Instruments) Show less

Handling of unplanned deviation , market complaint , OOS reports. • To monitor the Quality Assurance activities on the production floor w.r.t. the manufacturing and packing of the formulation i.e. tablets, Capsules.• To certify the area/line clearance prior to commencement of manufacturing activities for a batch as per cGMP guidelines.• Online audit of batch manufacturing records to ensure the proper recording of the data.• final Review of batch manufacturing record and release… Show more Handling of unplanned deviation , market complaint , OOS reports. • To monitor the Quality Assurance activities on the production floor w.r.t. the manufacturing and packing of the formulation i.e. tablets, Capsules.• To certify the area/line clearance prior to commencement of manufacturing activities for a batch as per cGMP guidelines.• Online audit of batch manufacturing records to ensure the proper recording of the data.• final Review of batch manufacturing record and release of the batch for packaging.• In process, quality control checks on the tablets & Capsules for the corrective action if any.• To perform calibration and Verification of IPQC instruments.• Online document and records review like equipment logbooks, dispensing logs, environmental monitoring records, calibration records, batch records• To perform AQL (Inspection) and sampling for finished product for stability studies and finished product analysis.• To perform Sampling of Process validation batches and online filling of process validation protocol.• Collection and Sampling of hold time study samples and Inprocess samples at different stages of manufacturing.• Online Data collection for Continues process verification. Handling of OOS and deviation (planned , Unplanned ) , preparetion of CPV( Continues process verification report)Preparation of APQR ( Annual product quality review) Show less

Preparation of Master Batch manufacturin record and Batch packing records, In process quality assurance activity.

Handling of “Out Of Specification” as team member with respect to chemical and Stability.• Preparation and Documentation of “Annual Product Quality Review”.• Brief knowledge on handling of remaining QMS Documents.Handling process validation activities on production floor as validation team member.To monitor the Quality Assurance activities on the production floor w.r.t. the manufacturing and packaging of formulations i.e. Tablets, Liquid Oral, Dry Syrup and Parentral.To… Show more Handling of “Out Of Specification” as team member with respect to chemical and Stability.• Preparation and Documentation of “Annual Product Quality Review”.• Brief knowledge on handling of remaining QMS Documents.Handling process validation activities on production floor as validation team member.To monitor the Quality Assurance activities on the production floor w.r.t. the manufacturing and packaging of formulations i.e. Tablets, Liquid Oral, Dry Syrup and Parentral.To ensure the conformance of systems and work practices with the standard operating procedures based on current good manufacturing practices.To certify the area/Line clearance prior to commencement of manufacturing /packaging activities for a batch, as per cGMP guidelines.On line audit of batch manufacturing records & batch packing records to ensure the proper recording of the data.In process, quality control checks on the tablets, with information to concern section in charge for the corrective action, if any.To give the clearance for the transfer of finished goods to BSR after verification of the finally packed goods against the batch records.Inspection and sampling for finished product for stability studies.Handing of deviations and change control regarding manufacturing activities.Coordination with other Departments for smooth functioning.Achievement During Industrial ExperienceFaced W.H.O, Ukraine, Sudan (MOH), Oman (MOH), Uganda (NDA), Tanzania(MOH) and some Customer Audits. Show less