Prashant Singh Email & Phone Number

Vadodara, Gujarat, India

Vadodara, Gujarat, India

• A dynamic Master of Pharmacy professional with 10 years 8 month of experience in Tablet and Capsule Manufacturing, Equipment Qualification, Production Planning, Yield Improvement,Training, Equipment Purchasing,change control and deviation, CAPA,SAP Activity ,SOP preparation,Trouble shooting of manufacturing process, and various activity in Pharmaceutical Industry.• Currently working as Deputy Manager – Manufacturing(Compression & Capsule) at Alembic Pharmaceuticals Ltd. Panelav, Vadodara• Proficiency in Tablet and Capsule Manufacturing, Qualification, SOP Preparation, Planning, ANDA Batch Execution, Yield Impprovement, • Last assignment was with Cadila Pharmaceuticals Pvt. Ltd., Dholka, AhmedabadCore Competence• Tablet Manufacturing(Granulation, Compression, Coating, Inspection)• Capsule Manufacturing• Equipment Qualification(URS, DQ,IQ,OQ,PQ)• SOP Preparation • Yield Improvement• Validation • Audits USFDA, MHRA,ANVISA, TGA, WHO.• New Equipment Procurement & Qualification• Production Planning & Execution• Leadership skills.• Training• change control, deviation and CAPA,• SAP Activity • Trouble shooting of manufacturing process. • Cost saving projects• To control and maintain the inventory of spare parts of machines, Tooling management.• Exposure in equipment qualification includes:• Compression machine(SEJONG , CADPRESS II, Rimek)• Capsule filling machine (AF-40T, AF-90T, ZRO 200T, FLUIDOCAP 40, Bosch GKF-2600)• Auto weight checker(Sejong iw120, Bosch KKE- 2700) • Involved in procurement and qualification• Document preparation URS, DQ,IQ,OQ,PQ.

Panelav, Halol

Vadodara Area, India

RESPONSIBILITES:-• On line Documentations as per regulatory requirements.• URS preparation for equipments.• Indenting activities for day to day departmental requirements.• Involve in equipments DQ ,FAT,SAT, IQ, OQ, PQ activity and protocol prepration and review • Equipments installation activities management in co-ordination of engineering department.• Preparation, Review and Compliance of SOPs related to Tablet and capsule Manufacturing• Protocols preparation and review for departmental requirements.• Initiation & closing of change control.• Handling of Deviation and CAPA.• Quality and cGMP Compliance in the section• Training to juniors and subordinates.• Exhibit batch manufacturing• Trouble shooting of manufacturing process.• Facilitator of yield improvement.• Facilitator of overall equipment efficiency(OEE) improvement.• Co-ordination with other departments like QA, QC, Store & maintenance to achieve production targets as member of CFT Team.• Active participation in various regulatory audits like USFDA, MHRA, ANVISA.• Review of Batch manufacturing record• Preparation of Daily Production Plan and Execution of the same• Maintaining discipline in the department• Active Participation in qualification activity of machine• Active participation in validation of batches• Procuring of equipment and its change parts, die-punch and ancillary items for department• Operation and Handling of capsule filling machine AF-40T, AF-90T, ZRO 200T.• Operation & Handling of compression machine BOSCH –MANESTY- 49S, BOSCH –MANESTY- 61S, CADPRESS II -37S.

Dholka, Ahmedabad

RESPONSIBILITIES:-• Total production activity of Compression and its monitoring with day-to-day basis and achieving the same with the quality products.• Quality and cGMP Compliance in the section• Preparation, Review and Compliance of SOPs related to Tablet Manufacturing• Review of Batch Manufacturing Record• Preparation of Daily Production Plan and Execution of the same within pre-scheduled time limits• Maintaining discipline the department• Active Participation in qualification activity of machine• Active participation in validation of batches• Active participation in ANDA batch execution• Training to subordinates• Operation & Handling of compression machine Rimek 117S, 61S, 75S, 51S, 45S, 37S, 27S.• Tooling manegement Handling of dies and punches, Punch Inspection• In-Process checks (weight variation, hardness, friability, D.T. ) during compression. • Documentation as per cGMP.• To maintain all supporting documents of compression department• Manpower handling & effective allocation of manpower as per norms defined for standard productivity.• Co-ordination with other departments like QA, QC, Store & maintenance.

Amaliya Daman

RESPONSIBILITIES:-• Operation and Handling of capsule filling machine AF-90T, ZRO 200T, FLUIDOCAP 40.• Operation & Handling of compression machine SEJONG HRC- 61S, SEJONG HRC- 49S , CADPRESS II -37S.• Direct supervision of stage of manufacturing of compression and capsule filling operations & cleaning of equipment used in compression and capsule filling operations• In-Process checks (weight variation, hardness, friability, D.T. & locking length) during compression & capsule filling. • Recording of Environmental Conditions in prescribed documents• Execution and fill up of BMR for Granulation, Compression, Coating and Capsule Filling• Dispensed material checking & documentation as per cGMP.• To maintain all supporting documents of compression and capsule filling department• Achieving the Production targets within pre-scheduled time limits. • SAP Activity like COR6N, MB31, MB1A, MD04, ZCP14, ZMLABEL and ME51N etc• Involved in manufacturing of validation batches. • Calibration of equipments like capsule filling machine, compression machine, In-process equipment, Balance etc.• Change parts and Tooling management, Punch Inspection.• Manpower handling & effective allocation of manpower as per norms defined for standard productivity.• Organizing training programs for subordinate.• Weekly production planning & preparing daily production report.• Co-ordination with other departments like QA, QC, Store & maintenance.• Active participation in preparation of various regulatory audits like USFDA, MHRA, WHO (GENEVA), TGA.

M Pharma, Pharmacy, 77.28%. 1St Division Withhonour

Activities and Societies: Completed research project work on the topic “Standardization of Selected Indian Medicinal Plants.

Bachelors Of Pharmacy, Pharmacy, 70.6%. 1St Division

Intermidiate, Science, First Division

Science Bio

Highschool, Science