Expert in Pharmaceutical Manufacturing (solid & Liquid dosage forms), Facility design, equiptment machineries selection, production planning, scheduling, work allocation/distribution. Staff selection and assesing their skill and knowledge level. Sketch job responsibility and reporting format for various jobs. Thorough and hand on experience with formulation development by QbD procedure. Indepth knowledge of stability studies. Expertise in analytical method development/Validation by (HPLC, UV/VIS, IR, etc). Fimiliar with all documentation requirement for ANDA/QOS submission with regulatory bodies. Justification of Formulation and Process with respect to QTPP/CQAs. Linking materials attributes and process parameters to CQAs, performing risk assesment. Design Space development from multivariant experiments to identify critical process parameters and their operating range.
ASQ membership, Certified Six sigma green belt
Technical Operation Controller Lagos, Nigeria
August 2005 --- June 2014
AT MAY& BAKER NIGERIA PLC (08/2005 TO 06/2015)
· Outline the new product development project, with list of products, time line of activities, and resources.
· Provide details of each project starting from Pre-formulation studies to verify effect of material attribute on CQAs, Materials attributes, Materials requirements, Trial formulations (DOE), List of Ingredients, Process outline with control parameters, Packaging materials and specification etc.
· Divide the main project into small activities and arrange the activities on time frame for action. Allocation of activities to the team members with list of activities, resources required to perform those activities.
· Periodically take updates from the team members for ensuring the timely and successful completion the project.
· Help team members in their execution of activities in case of problem or hurdle.
· Send report to Managing director on the project progress on various products separately.
· Maintain the project budget within control.
· Maintain the project team execution ability by providing regular training on Time management, good planning habit, good recording keeping, Regulatory requirements, and technical updates.
· Support QA for development of Master manufacturing document, decide on critical process parameters, Process Validation, Cleaning validation, Method Validation, Stability studies protocol and testing, Planned and unplanned deviation, API specifications, Semi finished product specification, Finished product specification, packaging materials specification, Storage and shipping condition for APIs, and Semi-finished – finished goods.
· Train Production staff for efficient and safe operation of Pharmaceutical equipments and machinery. Provide training for staff on recording of production activities correctly. Explain the operatives for proper handling and dispensing of Active and In-Active ingredients.
· Suggest cost cutting step on process and methods.
· Provide feedback to Production and QA on purchase of new machineries.
· Provide support to QC on Qualification and Calibration of equipments.
· Provide inputs for filling QOS for WHO prequalification dossier submission.
· Design and monitor scale up activities from Trial, Pilot to exhibit batches.
Formulation Development Manager Palghar, Maharashtra, India
May 1998 --- July 2005
Job functions Executed at Saphire Lifesciences;
· Design and conceptualise new product formulation as per customer’s requirements. Include statutory requirements into the products specification.
· Liaise with Procurement department for making resources available.
· Brief the developmental team on the path and time line.
· Assist the team in execution of the activities.
· Update the customers on their products status and send them samples for approval.
· Intimate QC/QA team for analytical method development.
· Collate data and documents for Dossier preparation team.
· Make manufacturing procedure for commercial production and in-process control parameters.
· Review products quality and suggest improvements & cost control.
· Review suppliers for quality failures.
· Write API and Inactive ingredients specifications.
· Provide inputs to QC/QA on critical process parameters.
· Design packaging materials and write their specification.
· Train project team for updated in technology, brief staff on functionality of new inactive ingredients, Process parameters and its effect on product quality.
· Provide GMP training to Production staff.
· Provide safety tip to production staff.
· Travelled to Philippines for shorting out dossiers defect and understand regulatory requirements.
Assistant Production Manager Vapi, Gujarat, India
February 1998 --- April 1998
Job function executed at Themis Chemicals Ltd.
· Day to day planning of Production and monitoring the daily output and prepares report.
· Prepare materials requirements for the three months and follow up with procurements department.
· Liaise with QC department and discuss production plan for timely release of the materials for production and finished goods for dispatch.
· Intimate QA production plan for availability of documents on time.
· Study Ware house stock statement for availability of materials a week ahead of production.
· Arrange weekly meeting with Production manager and production staff for discussing production problem and production planning.
· Plan weekly and monthly preventive maintenances programme of manufacturing equipments, Utilities, Building, lighting and surrounding environment.
· Attend Monthly with marketing department head quarters at Mumbai to discuss the availability of finished goods and include/exclude products from original plan.
· Train production executive for GMP operation, Data entry in Manufacturing records, Product yield calculation, correctly record residue (reworking) generated during production activity. Cleanliness in production area, how to avoid cross contamination of products, safety procedures, daily production reports and manpower utilisation report.
· Training to Production supervisor and machine operatives for GMP and safety operations in manufacturing area.
· Interact with Operatives to understand the cause of failure and decide corrective actions.
· Motivate executives, supervisor, operatives and packers to work in direction of achieving zero defects and support them with study materials, video demonstration, and personal demonstration to make them understand their process well to achieve excellence.
· Supervised activities of two executives, ten supervisors, fifteen operatives, fifty to sixty Packers and others around ten in cleaning and scavenging section.
Production Executive Pune, Maharashtra, India
July 1994 --- January 1998
Job function executed at Lazor laboratories;
· Receive work order from Assistant Production manager and plan weekly activities.
· Daily work distribution to all production pharmacists on daily basis and check their output at end of the shift. Shift distribution for all Production Pharmacists.
· Check the production documents for appropriateness and compile them for QA.
· Monitor production pharmacist’s activities while they are performing their duties for adherences to GMP procedure, timely and proper recording of production activities in BMR, and Maintenances of cleanliness in their departments.
· Plan periodic maintenances and breakdown maintenances with engineering department.
· Inculcate discipline of wearing safety and protective gears in production area by all operatives and staff.
· Prepare Machine performance specification for ordering new machine.
· Perform periodically calibration activity for pressure gauge, Temperature indicators and controller, Speed of rotation for chopper and impeller with help of maintenances/Engineering department.
· Carry out annual performance qualification of existing Tablet compression machines, Blister Packaging Machine, Automatic tablet coating machine, Cream tube filling machine, Planetary mixer, High Shear mixer.
· Execute Process validation plan for each product annually to maintain process status under control.
· Train staff for Quality Audit by conducting pre audit before actual audit from Glaxo, Pfizer, Johnson & Johnson, and Novartis.
· Keep production staff well versed with updated information on GMP.
· Audit Manufacturing facility for evaluation of GMP status, evaluation of staff skills and proper understanding of SOP, system procedures, Operatives skill and habits. Using Audit information training need for staff is proposed to higher management.
· Gaps and short falls highlighted from audit outcome are closed by imparting proper training to the staff, and Corrective / Preventive actions.
Assistant Production Chemist Dahisar East, Mumbai, Maharashtra, India
June 1985 --- June 1994
Jobs function executed at Labela Pharmaceutical Pvt. Ltd. (06/1985 to 07/1994)
· Supervise manufacturing activity in Granulation section. Record details of manufacturing activities in BMR.
· Supervise Tablet compression and carry out in-process checking of tablet parameters. Record the parameters and yield in the BMR.
· Intimate QC for sampling of semi-finished product for testing.
· Supervise Primary packaging activities. Record machine parameters carry out in-process checks and record in BMR. Record input and output reconciliation statement in the BMR.
· Submit the completed BMR to production head for his comments and finalization.
· Daily calibrate weighing balance at start of the shift.
· Periodical calibration of temperature probe of Fluid bed driers, Packaging machines.
· Maintain cleanliness of the departments during production activity and avoid cross contamination of products.
· Maintain storage area and daily record three times RH and Temperature of storage area.
· Supervise product change over cleaning activities.
· Arrange production materials for new products change over.
· Prepare finished goods dispatch documents, gate pass, Excise duty clearance.
· Prepare monthly production report and raw materials stock report for Production Head.
· Participate in machine overhauling and maintenances with engineers for better understanding of machine’s operations.
Analytical thinkingProblem solvingInterest in knowledgeIndependenceCollaborationCritical thinkingCreative thinkingCuriosityAttention to detailStrategic thinking
R&DBioavailabilityData AnalysisGood Manufacturing Practice (GMP)Pharmaceutical IndustryProject ManagementProtocolQualificationQuality Assurance (QA)Registration of the productRegulatory RequirementsScientific methodologyStatistical considerations in design and analysisStatisticsWriting Study Procedures and SOPsCAPACardiologyPharmacokineticsProduct design
Skills and Expertise
Analyze data Build the CMC development plan Create SOPs Control data Develop protocols Lab scale batches Report data Technology researchAdjust methodsAdjust processes Administer logisticsAdministrative supportAnalyze proteinAssess site feasibilityAttend seminarsChemistry Manufacturing and Controls (CMC) activitiesCoordinate CMC-activitiesDetermine statistical analysis Determine potential relationshipsDevelop ICH/GCP compliant processesDevelop regulatory strategyDirect co-workersEnsure data integrityEnsure data consistencyEvaluate impurity identificationEvaluate physico-chemical dataEvaluate physico-chemical data of lab scale/pilot scale batchesEvaluate post-marketing surveillance studyEvaluate stability data Evaluate stability data and impurity identification/synthesisExtrapolate dataFollow-up of external auditsFollow-up of internal auditsFollow-up of quality assurance activitiesFollow-up of Quality Management System (QMS) processesForecasting of drug productGenerate regulatory submissions Implement data collection systemImplement data reporting systemsImplement Quality Management System (QMS)Interpret dataManage laboratory proceduresManage projects resourcesMonitor dataNegotiationObserve trends in dataOperate research equipmentProvide trainingPublish scientific projectsQuality control processQuality testing of Investigational Medicinal Products (IMPs)Read medical literatureRegulatory documentationRegulatory submissionsReport dataPublication of articlesResolves queriesReview data interpretationReview quality control activitiesReview study protocolsReview vendor reportsSet-up quality policiesSolve problemsSolid state development Statistical analysisSetup of research equipmentStudy execution planSupervise data processingSupervise techniciansTranslate protocol into packaging and labeling requirementsVerify dataValidate dataWrite statistical reports
Bachelor in Chemistry from Mumbai University in 1983
Training and Certification
Six Sigma Green Belt in 2014 Certification