Shahzad Afzal Email & Phone Number

Karachi, Pk

Karachi Division, Sindh, Pakistan

Karāchi, Sindh, Pakistan

Karachi And Lahore

https://scitechinternational.org/our-companies/

Karachi

Reporting to Regional Quality Leader AMEEA division based in Belgium & Turkey.Responsible for establishing / monitoring and maintenance of Quality system to ensure product produced in the factory are safe and consistent ( validated ) to consumers and customers and met the Ontex Global quality specs.Restructured the Quality Organization to ensure both Global Quality and Productivity targets were met leading to a self-sufficient organization. Delivered more than 20 Million PKR saving per month through product optimization through R&D initiatives..Responsible for maintaining Quality system health through internal audits, Certification audits of FSMS, QMS, OSHAS, BSI, and ISO 17025. successfully attain certification without major non conformities.Responsible for tracking consumer complaints and implementation of actions by way of CA's and RCPS and successfully reduced the complaints level from 5PPM to 0.115 PPM.Responsible for establishing, monitoring of compliance of process CPP's, CPS's to ensure process control during manufacturing of each SKU produced in the factory.Responsible for implementing & tracking SITE Quality Master Plan in line with Global Quality Master Plan the focus areas of Quality Master plan are Quality culture, supplier Quality, Mfg. Excellence and Quality foundation and compliance.Responsible for Coaching on RCPS sessions and addressing problems through RCPS tools( 5W2H,Base Condition checks, Fishbone, Why-Why, Action tracking etc. successfully reduced defect on selected Top three defects from 5.1 events per million pieces to 1.0 and 2.6 to 0.8 respectfully after implementation action from Sep-2021.Lead the transformation projects at SITE (Operational excellence, MES, QIS, etc)Successfully completed FAT (Remote), SAT/ IQ/OQ/PAT/PQ in Factory for two new lines during Covid-19 and completed GO TO MARKET.Responsible for Raw material supplier audits and trials on SITE for AMEEA division to ensure every new RM/PM validated.

Site Karachi

Participated lead role in Area approval ( Opthalmic , dry suspension , injectables ) from DRAP in short time in previous assignment.Managing Quality assurance and regulatory affairs department .Management Representative for ISO 9001 and 14001.responsible for timely submission of registration dossier for MOH Pakistan.Successfully get approval from DRAP for new product , new molecule registration , imported drug , change of brand name , renewal of already registered product and transfer of registration in previous assignment etc such as:I. Clindamycin phosphate 1.2% and Tretinoin 0.025% creamII. Nadifloxacin 1% w/wIII. Clobetasol Propionate USP 0.05% w/w & Gentamicin sulphate BP (Eq.to Gentamicin). 0.1% w/w creamIV. Dextran 70 & Hypermellose eye dropsV. Netilmicin sulfate eq. To netlimicin /dexamethasone sodium phosphate eq. To dexamethasone eye dropsVI. Ciprofloxacin suspension VII. Gentamicin sulfate equivalent to Gentamicin base 0.1%, Betamethasone valerate equivalent to Betamethasone 0.05% , Tolnaftate 0.1% , Clioquinol 0.1% cream.VIII. Gentamicin sulfate equivalent to Gentamicin base 0.1% Betamethasone Dipropionate equivalent to Betamethasone 0.1% creamIX. Clarithromycin suspension 1256mg/5mlX. Arthemether / Lumefantrine dry suspensionXI. Lacosamide InjectionXII. Moxifloxacin InjectionXIII. Solifinacin succinate tablets , ophthalmic suspension and cream in previous assignments.responsible for conduct internal audit program as per cGMP guidlines.Responsible for in process control (Tablet, sterile, Creams and Opthalmics) Review and implementation of batch manufacturing and batch packaging record.Responsible to ensure that all production activities are carried out according to GMP guidlines

Karachi

Managing QA/QC activities.Stability studies planning , execution and data management .Export Audits from Ghana , Nigeria , Sudan .Responsible for overall validation activities.ISO 9001:2008 , ISO 14001 and ISO 18000 certification .Controlling in process, cGMP, in production and sterile area .reviewing BMR and QA documents.sop's preparation and review.Iso audits and compliance.inhouse and coordinate with external supplier for all instruments calibration and troubleshooting.conduct trainings on HPLC, FTIR, AA6300 etc.preparation of approved venddor list.team member for internal audits for cGMP.

Batch record review .Responsible for Preparation of stability studies plan, realization and data management.Annual Product Review Responsible for validation master plan.PQ of sterile area , WFI , HVAC analysis of raw material, finished product.stability testingnew product method developmentin process method validation

Karachi

Analysis of raw material, finished product and packaging material inprocess control audit of batch history, batch record.formulation development of new product.

M.Sc., App. Chemistry

Activities and Societies: App chemistryApp chem

Diploma In Computer And Information Sciences, I.T.

app chemistry

H.S.C., Science (Pre.Engg.)

science

S.S.C., Science

science