Area OF JOB FUNCTIONS: Pharmaceutical Sterile injectable Production and project.

ORGANIZATIONAL EXPERIENCE:

Currently associated with Zenzi Pharmaceutical, group of Alpha Pharma, Murbad, as Senior Manager Production project from September 2019 to till date.

Worked with Sophal pharma. Oran, Algeria as a Production Head Sterile from June 2015 to June 2019.

Worked in Sandoz Pvt. Ltd, Navi – Mumbai, India as a Production officer from March 2008 to May 2015.

During 01 Jan to 30 Aug 2010 on International assignment (from Sandoz) for manufacturing of H1N1 Vaccine in Novartis vaccine & diagnostic ltd., Liverpool, UK.

Profile in Novartis: Downstream manufacturing includes virus seed serial dilution, inoculation of egg with virus, incubation, blast chilling, harvesting of fluid, centrifugation, filtration etc. checking & completion of manufacturing instruction

Worked in Wockhardt Ltd. Biotech Park, Aurangabad as Production Chemist from June 2005 to Feb. 2008 in Biotech (Insulin) and ANDA formulation.

Core Competencies:

cGMP/ handling of whole plant/team building

Self-Inspection/Internal Audits

Manufacturing Investigation /CAPA

Quality Management System

Manufacturing Operation

Resource management

Document Control

Protocols

Validations

MFR/MBR/BMR

Deviation

Operational Excellence

SOP’s/PPT Presentation’s

Technical/Operations training

Project executions

Highlight of the Skills:

A dynamic professional with nearly 15 years & 03 months of experience in Pharmaceutical and Healthcare sector.

Currently associated with Zenzi Pharmaceutical Industries Limited, Mumbai, India as Senior Manager –Production and Potent hormone project.

Comprehensive experience in equipment / systems validation process which relates to establishment of documentary evidence depicting procedure, process or activity which is undertaken in production, testing and warehousing areas by ensuring maintenance of desired level of compliance at all stages.

Comprehensive experience in equipment / systems validation process which relates to establishment of documentary evidence depicting procedure, process or activity which is undertaken in production, testing and warehousing areas by ensuring maintenance of desired level of compliance at all stages.

Experience in GxP impact assessment as per ISPE guidance, Functional &Quality riskassessmentasperICHQ9 &GAMP 5 and Part 11 assessment as part of 21CFR.

Hands on experience in Process validation and cleaning validations as per current regulatory requirements.

Proficient in developing & streamlining validation systems with proven capability to enhance operational effectiveness and meet operational goals within the cost, time& quality parameters.

Sound practical knowledge regarding capacity, planning and conducting validation activities and participating in regulatory and internal audits.

Experience in conceptualizing profitable production operations encompassing procurement, quality and industrial relations.

Skilled in enhancing production process operations, optimizing resource utilization, escalating productivity and operational efficiencies.

Possess strong research, analytical, problem-solving and interpersonal communication skills.

Sophal Dz. Job Profile:-

Execution, gap assessments of various projects as a formulation expertise.

Handling of whole dry powder injectable operations.

Successfully completion of qualification, validation and operation of all production equipment and systems related to sterile product i.e. steam sterilizer, vial washing, vial sterilization, vial filling and stoppering, vial sealing and Packing as per the cGMP requirements.

Successfully start-up the plant for commercial production and achieved the target of 18 million vials per year.

Compliance of cGMP and safety norms related to production activities, with respect to Aseptic processing.

Ensure Strict adherence to set quality and safety standards.

Train Operators and Associates to achieve the multiple skills.

Review of Documents related to Qualification of equipment, SOP, Batch Manufacturing Records, Batch Packaging Records, pertaining to sterile FDF.

Coordination and follow up with the vendors as well as cross functional departments.

Effective utilization of manpower for achieving daily targets.

Planning of daily shop floor activity related to Production.

To lead and motivate team of Production in order to achieve the set targets.

To perform / review the investigation in case of any deviation, OOS at shop floor.

Review of change control, investigation report, protocol, SOP, batch manufacturing record, batch packaging record etc.

Sandoz Profile:-

Checking & reviving of BMR, BPR’s, and daily log books.

Review and compliance of Validation reports of: HPHV Steam sterilizer, Depyrogenation tunnel, Vial washer, Media fill simulation.

Aseptic Blending and filling of Meropenam & Imipenam.

Completion and reviewing of BMR, BPR and daily log books.

Working on SAP system.

Review of IQ/OQ/PQ & DQ of all equipment’s and machines.

Catering training to the subordinates, collogues and compliance of the training records thereof.

Faced EU Audit successfully during the short tenure with Sandoz Pvt. Ltd.

Wockhardt Pvt. Ltd. Profile:-

Strong Manufacturing knowledge of :

oWosulin (Insulin vials and cartridges -N/R/50-50/30-70)

oWepox (Erythropoietin 0.5-1ml PFS & 3ml Vial)

oANDA Injectable and ophthalmic exhibit batches.

Zenzi Pharmaceutical Pvt. Ltd. Current Profile:-

Handling of plant activity.

Execution of high potent hormone project, project is in a final phase.

Preparation of all production related documents and execution of facility start-up validation.

Planning of initial media fill and stability batches and preparation of FDA facility audit.

Equipment handled:

Vial washing & De-pyrogenating Tunnel– Macofar Italy/DARA Spain/Klenzaide-India

Liquid Vial Filling & Sealing – Mar Italy/DARA Spain

Dry Powder Filling & sealing Machine – Macofar - Italy/DARA Spain

Steam sterilizer - Machine Fabrik/Indo German – India, Fedegari- Italy,Trucking & Sinva China.

Pre-filling syringe & cartridge Filling – Mar Italy

Vial and Ampoule filling machine – Rota Germany

Ampoule filling machine – Rota Germany

Lyophilizer – Tofflon / Trucking China.

Audits EXPOSURE:-

Worked as a team member for following Audits

USFDA, TGA, EU & WHO.

Faced US Auditor in 2014.

FAT EXECUTION:-

Fedegari Autoclave, Pavia, Italy

Romaco Vial filling whole line, Bolognia, Italy

OMAR blister pack, Milan, Italy.

DARA vial filling whole line, Barcelona, Spain.

Trucking Lyophilizer line, Changsha, China.

Sinva Autoclave, Jinan, China.

Brevetti CEA SPA vial inspection machine, Italy.

EDUCATIONAL QUALIFICATION:-

B. Pharmacy from Mumbai University.

Diploma in Pharmacy with distinction from MSBTE, Mumbai.

Achievement :

Potent hormone project commissioning and qualification done successfully in Zenzi pharmaceutical.

Successfully completion of Cephalosporin project and started commercial production in M/S Sophal Pharma, Oran, Algeria.

Project lead done for liquid injectable, eye/ear drop, corticosteroids lyo injectable in Sophal.

In a Sandoz Pvt. Ltd. Mumbai, as a team Successful completion of Carbapenem dry powder – injectable project.

Award for ‘Successful completion of medial fill in new facility’ without failure.

Successful completion of ‘Oxygen content in vial NMT 3%’ project.

Successful completion of validation activity of new facility.

Award for creative Sandoz idea ‘Trolley for co-mill head’

Award for Sandoz idea to reduce the viable count in pass box.

Personal Information:

Date of Birth : 20/06/1980

Nationality : Indian

Marital status : Married

Sex : Male

Language Fluency : English, Hindi, Marathi

Leisure Activities : Reading, Learning something new

Pass Port No. : U0122712

Skype ID : jayant.gaikwad

Present Address : D-305/306, Amzona CHS,

Cas Rio, Palava city,

Dombivili (E), Thane.

Maharashtra (India)

Reference : MR. Suresh B. Hore, Asia Head- Eli-Lily, Hyderabad.

+91-800*******

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