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API Manufacturing

Location:
Chandigarh, India
Posted:
September 12, 2023

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Resume:

CURRICULUM VITAE

JAIDEEP KUMAR VERMA

Mail ID: adznor@r.postjobfree.com

Mobile: 099********, 078********

Sr. Manager Production

Key Professional Highlights:

Skilled in handling of APIs /bulk drugs/chemicals manufacturing blocks at senior position.

Manpower handling and other Production related activities, In house co-ordination with Project department, Quality assurance & Quality Control, HR, Maintenance & EHS departments

Excellence in ensuring quality standards and statutory requirements involving cGMP & GDP for product quality, in-house quality and documentation as per the regulatory guidelines.

Skilled in IPQA, taking process improvement and quality systems initiatives for enhancing production efficiency.

Expertise in preparing investigations, handling of change control records, handling of deviations, CAPA management, LMS for training and DCM for SOPs

Review of development reports, periodic progress reports and other documentation like exhibit / validation protocols.

Profile Summary:

•Currently working with M/s Vincit Lab Pvt Ltd (Punjab) as Assistant General Manager in Production department & responsible for manufacturing of APIs/Intermediates of multiproduct.

•Worked with M/s Akums lifesciences Ltd, Lalru (Punjab) as Sr. Manager in production department & responsible for manufacturing of APIs/Intermediates of multiproduct three manufacturing blocks which have 43 reactors (including Cryo reactors) of total 131 KL capacity. I am reporting to AVP operations.

•Worked with M/s Srikar Laboratories Pvt. Ltd, Vishakhapatnam (Andhra Pradesh) as Sr. Manager Production & responsible for the position of Plant Head manufacturing of APIs/Intermediates in three multiproduct manufacturing blocks which have 50 reactors of total 120 KL capacity, apart from this also responsible for warehouse & logistics. My direct reporting was to MD.

•Worked with M/s IOL Chemicals & Pharmaceuticals Ltd. Barnala (Punjab) as Assistant Manager Production & responsible for one independent multiproduct APIs/Bulk drugs manufacturing unit.

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•Worked in M/s SUN Pharmaceutical Industries Ltd (erstwhile Ranbaxy Laboratories Limited) Village Toansa, Punjab.

I was at the position of Manger Production (Module Incharge) in APIs/Bulk drugs manufacturing since year 2010 & responsible for the three manufacturing modules (API manufacturing, intermediates manufacturing & Spray dryer for spray drying of Nutraceutical product) which have total 33 reactors (including Cryo reactors) of total

103 KL capacity..

•Total strategic professional experience in spearheading production operations & quality improvement projects and while meeting business needs in a fast paced, dynamic and globally expanding MNC environment.

•Managerial experienced in enhancing the production & process operations, optimizing resource & capacity utilization; escalate productivity & operational efficiencies.

•Proficient in Quality Control Management in Pharmaceuticals Industry while ensuring cost & timeline parameters as per Standard Operating Procedure (SOP).

Academic Details:

•Bachelor’s Degree in Science (Non Medical) from Guru Nanak Dev University, Amritsar in

1986.

•M.Sc. (Applied Chemistry) from Karnataka State Open University (Distance Education) in

2014.

Organization Experience:

Organization:

Worked with Sun Pharmaceutical industries Limited (erstwhile

Ranbaxy Laboratories Limited) Toansa, Punjab.

Designation:

Manager Production – API Manufacturing

Duration of service:

Nov. 1989 to Jan, 2019

Production Chemist:

01.11.1989 to 31.12.1996

Detail of duration:

Production Supervisor:

01.01.1997 to 30.06.2007

Sr. Production Executive: 01.07.2007 to 31.12.2009

Manager Production:

01.01.2010 to 11.01.2019

Total: 29 years 3 months

Organization:

Worked with M/s IOL Chemicals & Pharmaceuticals Ltd.

Barnala, Punjab.

Designation:

Assistant Manager Production (M-1) – API Manufacturing

Duration of service:

March 2019 to Jan 2020

Detail of duration:

Eleven months.

Organization:

Worked with M/s Srikar Laboratories Ltd.

Vishakhapatnam (Andhra Pradesh).

Designation:

Sr. Manager Production -Manufacturing (Plant Head)

Duration of service:

24th, June 2020 to 31st, March

Detail of duration:

Nine Months

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Organization:

Worked with M/s Akums

Lifesciences Ltd, Lalru, Distt. Mohali

(Punjab)

Designation:

Sr. Manager –production

Duration of service:

6th, May 2021 to 5th, Aug 2023.

Organization:

Currently working with M/s Vincit

Lab Pvt Ltd, Banur, Distt. Mohali

(Punjab)

Designation:

AGM –production

Duration of service:

7th, Aug 2023 onward

Key Result Areas and Responsibilities:

•Performs Managerial duties including Production Plan scheduling, execution, prioritizing, procurement, hiring, training, timecard review, performance evaluation, and disciplinary action.

•Leading a team of Production chemists / Supervisors / Sr. Executives/Assistant Manager production / Deputy Manager Production for manufacturing of Advanced Process technologies to commercial scale with GMP & Regulatory guidelines.

•Co-ordination with API Research team for Scale up projects from R & D, Kilo Lab to Pilot Plant and ensuring the deliveries as per requirements.

•Ensures all completed Manufacturing batch records and Packaging batch records are reviewed for completeness and compliance with cGMP requirements and regulatory requirements

•Creates departmental budget. Optimum utilization of funds by avoiding unnecessary and avoidable expenses.

•Plant trouble shooting and to introduce necessary modifications / alterations as per the requirement of the process.

•Manpower handling and other Production related activities, In house co-ordination with Project department, Quality assurance & Quality Control, HR, Maintenance & EHS departments.

•Responsible for IPQA, Batch manufacturing, System control, Material movement control and as per SOP & cGMP requiring product change over & cleaning validations in multi product plant.

•Perform HAZOP studies for new Process and Hazardous raw material, handled successfully Palladium catalyst (5%, 10% ) wet as well as dry, Raney nickel . N-Butyl Lithium, Diabal, Bromine, and High pressure Hydrogenation.

•Develops functional processes for area managed and executes CAPAs, change controls, and investigations as assigned.

•In a period of more than 32 years, I successfully produced following APIs / Intermediates (bulk drug) of high quality and with very high yield involving Hazardous reactions like Hydrogenation, High pressure reaction etc.

Products: Ciprofloxacin, Norfloxacin, Sildenafil, Pentazocin Hydrochloride, Ramipril, Tamsulosin Hydrochloride, Celiprolol Hydrochloride, Citalopram Hydrobromide, Cilazapril, Donepezil, Fexofenadine Hydrochloride Galantamine Hydrbromide,Levitrastram,Imipenem,Cilastatin,Doripenem,Meropenem,Olanzapine,Rabeprazole Sodium, Rosuvastatin Calcium, Mandelic acid recovery, Clorazepate

Dipotassium,Telmisartan,Repaglinide,Lamivudine,Lansoprazole,Desloratadine,Febuxostat,

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Lorazepam, Simvastatin, Esomeprazole Mg.,Orlistat RMs(S-Alcohol & Oxtenone), Abirateronone

Acetate, Ursodeoxycholic acid, Lamotrigine, Clopidogrel, Fenofibrate, Pantoprazole Sodium, Citicoline Sodium, Atorvastatin Calcium.

•Defining SOPs (Standard Operating Procedures), product specification and standard testing procedure for APIs & Intermediates

•Completing documentation system including track wise for change control records, deviations, CAPA management, LMS for training and DCM for SOPs

Strength & Achievements:

•Able to coordinate and prioritize workload to meet stringent deadlines.

•Thorough knowledge of shop floor production system

•Facing audits which includes regulatory and customer.

•Capable of handling team as a team leader & interact supportively with team environments.

•Nominated in the years that is 2007, 2008, 2009 & 2011, 2013 in appreciate program for successfully carried out technology transfer revised process of cost reduction project like Celiprolol HCL, Citalopram HBr, Cilazapril, Imipenem and variation filed in US, Europe.

•Worked on Process development of high market share molecule Cilazapril cost reduction & Oxatenone critical molecule.

Core Competencies:

•Documentation

•Trackwise system

•SAP

•Quality Management

•Production Management

•Auditing

•Process Improvement

•Team Building & Leadership

Safety, Health & Environment:

•Followed MSDS data of chemicals and ensure entire manufacturing, handling / movement processes are carried out with utmost Safety in mind.

•All new process at Contract manufacturing location / In house location to be take up after Hazard analysis, information of new chemical used in the Products to respective person.

•Training of Supervisors and chemists for update them in recent technologies in Safety, Chemical, Software, cGMP and scale up issues.

Audit Experience:

Proficient with various Regulatory affairs audits e.g. FDA, EMA, TGA, WHO, ISO, CDSCO and many more Customer audits.

Training:

Impart training to employees on GMP, GDP, SOPs & Functional Topics and maintaining records.

Computer Knowledge:

MS Office, MS Excel, PowerPoint, Outlook, Internet, SAP, Documents Archival Management System, LMS System, DCM System, Track wise System.

Personal Details:

Father’s Name

:

Sh. Kesar Lal Verma

Date of Birth

:

26th, June, 1966

Gender

:

Male

Marital Status

:

Married

Nationality & Religion

:

Indian, Hindu

I hereby declare that above written Particulars are true to the best of my knowledge and belief.

Date

:

With regards,

Place

: MOHALI

(JAIDEEP KUMAR VERMA)

S/O Shri Kesar Lal Verma,

MIG # 2135-A, Sector-66,

Mohali -160062, (Punjab),

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