General Manager Contract Manufacturing
Resume:
CURRICULUM VITAE
VADHWA GURUDITSINGH ANOOPSINGH,
***, **** *********, ******** ************,
Bholav, Bharuch- 392001 (Gujarat)
E mail: ********@*****.***
Mobile: 823-***-****
Seeking assignments to Unit/ Site Head Operations with an organization of repute.
Professional Synopsis
Seasoned professional with 21 years of rich and insightful experience in all Operations, Contract Manufacturing, Auditing, Engineering, EHS, ETP, Administration & Technical services.
Presently spearheading the efforts to accomplish the corporate objectives of Reine Lifescience as General Manager- Site Head.
In RLS taking care of 2 Sites for API Manufacturing.
Working as Site Head. Taking care of Production, Contract Manufacturing, Warehouse, Engineering, Technology transfer, Purchase, EHS functionally reporting. HR, QA/ QC administratively reporting to me.
Hand on experience --- USFDA (2005, 2015, 2016), WHO (2015, 2018), Mexican (Cofepris 2015, 2019), Health Canada (2016), ISO 9001:2001, ISO 14001, OHSAS 18001 (2013, 2022)
SUMMARY:
Total 22 years of experience. API (18 years) & Chemical (4 years).
Nearly 10 years’ experience in Senior managerial level.
ORGANIZATIONAL EXPERIENCE:
1] REINE LIFESCIENCE (ANKLESHWAR, GUJARAT)
Joined as General Manager- Site Head Operations from 1st May 2024.
200 Cr. Turnover of Site.
API Intermediates: Atorvastatin Calcium, Rosuvastatin, Telmisartan, Metoprolol Succinate, Metoprolol Tartrate, Bromo OTBN, Pregabaline, Baclofen, Erdostein, Febuxstat, Doxophylline, Potassium Clavulanate...
API: WHO GMP compliant; ISO 9K, 14K & 45K approved.
Job Responsibilities:
2 Units (2 Intermediate blocks & 6 Pharma blocks (direct reportee 5 Nos. Staff 150+ Nos.
Ensuring Production plan execution in line with dispatch timelines.
Ensuring Safety Culture implementation all over the Site to avoid any incidents/ accidents.
Ensuring & Controlling Cost of Production, RMC, Operation Cost, Manpower Cost.
Ensuring standard yields
Ensuring GMP culture at Site & make Site 24*7 auditable.
Responsible for P&L of the Site and Legal Compliance (EHS, HR, Engg, Factory act).
New Product development projects to initiate and validation to carry out with technical inputs.
Chairing of Investigation team to ensure proper RCA, CAPA & ensuring actions implementation at ground level.
Implementation of HR & Admin policies to ensure compliances & improve the culture of the organization.
Ensuring projects execution such as Inventory control, Cost optimization, Capacity enhancement, Solvent recovery, EHS projects, Yield improvement, water reduction, power reduction, Utility optimization, Effluent reduction.
Taking care of Statutory Compliances for Environment, Pollution, Hazardous waste, Boiler, Factory and Engg.
Chairing Safety committee meeting every quarter and ensuring compliances as per company policy through long term & short-term projects.
Ensuring, Reviewing & Controlling Expenses vs Budget
Driving innovation scheme in production block to enhance moral & competitiveness of the production team.
Complete evaluation to MIS report
Taking care of Capex budget for the plant for increasing the efficiency of the plant by providing relatively small change in the hardware, new technologies & its implementation.
Reviewing Monthly performance of Operations & MRM presentation to Management
Contract Manufacturing: Intermediates such as RCMH, Br OTBN manufacturing through CMO.
Reporting to MD.
2] BASF INDIA LTD (JAMMU, J&K)
Joined as Contract Manufacturing Manager from 17th Apr-2023 to 31-04-2024
Taking care Agrochemicals formulations Contract Manufacturing Operations at Jammu, Derabassi & Ankleshwar Location (5000 MT/KL annually).
Brands such as Xelora, Merivon, Intrepid, Priaxor, Opera, Acrobat, Polyram, Sefina, Basagran, Lihocin, Cabrio Top, Basta, Acrisio, Signum etc
2000 Cr. Turnover of Site.
Job Responsibilities:
Taking care of Agrochemicals formulations Contract Manufacturing of 3 Units viz Saraswati Agrochemicals Ltd (Jammu & Derabassi) & Sayona Care Ltd (Ankleshwar)
Ensuring Renewal of Legal Documents, Confidential Agreements, Manufacturing licenses in collaboration with Legal & Regulatory team.
Ensuring documents for new product launches/ Old products renewal such as FMM, CIB, Licenses, Labelling, SOPs, MOA, Quality Agreements, CA, Hazop & PHA Study, Pilot trials, Validations in place before commercialization.
Providing technical inputs for new product launching for better technology transfer & ensure process safety.
Ensuring long-term profitability with respect to Tolling cost, RMC, Inventory control, Contracted Yields, Capacity utilization, Manpower utilization, RFT, Validations/ Qualifications.
Ensuring execution of Toller agreements & Contracts as per agreed terms & conditions. Monitoring monthly performance such as Plan vs Actual Production, Yields, Dispatches, Quality parameters against contracted. Ensuring incentive/ cuts against yields.
Ensuring online data SAP updation at Toller as well as BASF side.
Ensuring monthly MIS reporting, EHS Performance, Inventory Control & Costing, Stock taking of AI, RM & Consumables at all Toller Sites.
Taking care of Corporate EHS & Commercial Audits.
Ensuring Safety of Employee & Property of the organization by implementing Safety SOP’s, Hazop recommendations strictly.
Achievment: New Toller Site development such as Saraswati Agrochemicals (Derabassi), Sayona Crop science (Ankleshwar), PI (Panoli) by auditing EHS & Available facility point of view. Also ensuring fitment of new AI wrt to capacity utilization, batch size finalization, Utility requirement, technology transfer, Engineering modifications, HAZOP Study.
Reporting 3 Toller Site Heads, 3 Toller EHS Heads, 3 Toller side QA Heads, 11 BASF employees (Each SAP data entry-3, Warehouse-3 & Dispatch-3, SCM-2)
Reporting to Regional Technology transfer Manager (Indonesia)
3] KIMIA BIOSCIENCES LTD (GURUGRAM, HARYANA)
Joined as Head Operations & Management from 11th Oct-2021 till 29th Mar-2023.
200 Cr. Turnover of Site.
API Intermediates: Ethyl Thiazole (Acotiamide); 2,4,5 Trimethoxy Benzoic acid (Acotiamide); Lulicanazole Intermediates & API; Levosulpiride; Citicoline; Teneligliptin; Oxaceprol, UDCA; Vildagliptine, Fimasartan; Gliclazide; Benfortiamine; Delafloxacin; Obeticholic acid, Benidipine, …
API: WHO compliant; KFDA Approved, ISO 9K, 14K & 45K approved.
Job Responsibilities:
1 Units (3 Intermediate blocks & 8 Pharma blocks (direct reportee 7 Nos. Staff 200+ Nos.
Review Production plan as per Marketing requirements with timelines & delivery.
Responsible for P&L of the Site and Legal Compliance (EHS, HR, Engg, Factory act).
New Product development projects to initiate and validation to carry out with technical inputs.
Ensuring GMP compliances at Site as per ICH guidelines with the help of QA team.
Chairing of Investigation team to ensure proper RCA, CAPA & ensuring actions implementation at ground level.
Implementation of HR & Admin policies to ensure compliances & improve the culture of the organization.
Ensuring & Controlling Cost of Production, RMC, Operation Cost, Manpower Cost.
Ensuring cGMP, facility upgradation in compliance with Regulatory requirements.
Ensuring KRA of subordinates by undertaking projects such as Cost optimization, Capacity enhancement, Solvent recovery & EHS projects, Yield improvement, water reduction, power reduction, Utility optimization, Effluent reduction.
Taking care of Statutory Compliances for Environment, Pollution, Hazardous waste, Boiler, Factory and Engg.
Chairing Safety committee meeting every quarter and ensuring compliances as per company policy through long tem & short term projects.
Ensuring Audit readiness at all levels of Site in Co-ordination with QA Compliance team.
Ensuring Optimum inventory of RM, Solvents, FG, Engg spares & Consumables at Site.
Ensuring, Reviewing & Controlling Expenses vs Budget
Ensuring Safety of Employee & Property of the organization by implementing Safety SOP’s, Hazop recommendations strictly.
Driving innovation scheme in production block to enhance moral & competitiveness of the production team.
Complete evaluation to MIS report
Take leading part in fixing budgetary exercise in every year, to fix norms of the products based of marketing volume.
Taking care of Capex budget for the plant for increasing the efficiency of the plant by providing relatively small change in the hardware, new technologies & its implementation.
Reviewing Monthly performance of Operations & PPT presentation to Management
Empowering the team for better decision making & cost-effective solution findings.
Contract Manufacturing: New Site development for Solvent recovery (SK Solvents, Derabassi) & API active ingredients (Biovivid Chemicals, Rajpura). Sites Audit done wrt to EHS, Facility availability. Product fitments wrt to available Equipments & Utilities available. Costing of Operational cost including energy utilization. Finalization of Tolling cost/ Kg production with Toller. Legal Agreements, Quality agreements after mutual agreement on both sides. Nearly 50 Cr turnover with Contract manufacturing of Solvents & AI.
Reporting to MD.
4] SAURAV CHEMICALS LTD., DERABASSI (PUNJAB)
Joined as Unit Head from 20th Dec-2019 to 7th Oct-2021
350 Cr. Turnover of Site.
API Intermediates: 2-cyano-4-Bromomethyl Biphenyl (Bromo OTBN- KSM of Valsartan, Irbesartan.); Para Nitro Benzyl Bromide (Imatinib Mesylate: Cancer treatment); Bromo Butyric acid (Levitracetam- Anticonvulsants) Acetoxy Ethyl bromide (Cefuroxime- Antibiotic Cephalosporin).
API: EuGMP compliant, US FDA approvable API manufacturing facility. Pregabalin, Sildenafil Citrate, Dexketoprofen Trometamol, Homatropine Methyl bromide (HMT), Clopidogrel Besylate, Homatropine Hydrobromide (HMB), Febuxostat, Valsartan intermediates etc.
Job Responsibilities:
2 Units (2 Plants in Unit-1 & 3 Intermediate & 9 Pharma blocks in Unit-3), direct reportee 11 Nos. Staff 500 Nos (250 + 600).
Review Production plan as per Marketing requirements with timelines & delivery.
Owning the P&L of the Site taking responsibility of budgeting, strategic planning, resource allocation and human resources.
Reviewing plan vs Actual in daily meeting & ensuring service department supports to Operation team.
Taking care of Cost optimization, energy conservation, waste minimization, Capacity enhancement, Solvent recovery & EHS projects to ensure and achieve annual savings as per targets set by Management.
Taking care of Statutory Compliances for Environment, Pollution, Hazardous waste, Boiler etc. (PPCB, CPCB)
Co-ordination with QA for Audit preparation, visits, operation plans and document closure.
Taking care of inventory control of raw material, intermediates and finished products.
Reducing production cost by implementing right first time (RFT)/ failure reduction with effective root cause analysis and CAPA implementation.
Continuous improvement in Operations through Operational excellence tools such as 5S, Lean manufacturing, Kaizen & Six Sigma.
Co-ordinate with EHS department for achieving zero incident/ accident. Closing all the near miss observations in timely basis.
Maintain safety norms, as in force, usage of required & appropriate PPEs, Permit systems and implementation of various safety guidelines/ norms from time to time.
Experience of safe handling of Toxic & Corrosive gases such as Chlorine, Bromine, Hydrogen bromide, Hydrogen sulfide, formaldehyde, hydrogen chloride, Ammonia etc.
Administration to develop good teamwork, maintain discipline, motivate employees for long term period.
Work in close co-ordination with TT/ R&D team for new product validations in plant, Current product cost effective process improvements.
Monitoring production, technical evaluation, analyzing processes & debottlenecking of the processes to increase its throughputs thereby reducing overheads of that products.
Strengthening cGMP system as per ICHQ7 norms in the plant to reduce customer complain & improving standard of the plant.
Waste reduction at source / Water conservation / COD & hydraulic load reduction. Air pollution controls. Solid waste reduction
Coordinating training programs time-to-time to enhance the skills of the subordinates and as a result gain improved productivity.
Driving innovation scheme in production block to enhance moral & competitiveness of the production team.
Complete evaluation to MIS report
Green field project (Mitsubishi) is going on in Nimbua Industrial area for expansion in API products. (6 months). Related government Liasioning activities going on.
On monthly basis with action plan for improving product usage ratio/ overhead reduction.
Take leading part in fixing budgetary exercise in every year, to fix norms of the products based of marketing volume.
Taking care of Capex budget for the plant for increasing the efficiency of the plant by providing relatively small change in the hardware, new technologies & its implementation.
Heading Team which includes R&D, PDL, engineering persons for day-to-day problems or improvement in regular products.
Reviewing quarterly performance of plant with respect to production, quality, safety, cost savings projects, profitability, maintenance/ break down, utility consumption, waste generation.
Labor related issue solving through meeting with HR department.
Responsible for achieving budgeted norms of RMC, Consumables.
Monthly Performance PPT presentation of Site to Management.
Reporting to COO-Operations.
5] CADILA HEALTHCARE LTD., ANKLESHWAR (GUJARAT)
Worked as Executive – Production from 25th Dec, 2007 to 30th June, 2009.
Joined as Sr. Manager Production (Production Head/ Dy. Site Head) from 21st Sept, 2017 to 8th Apr 2019.
Ankleshwar site is 9K, 14, 18K, PMDA (Japan), USFDA & WHO (Europe & Geneva) certified organization.
240 Cr. Turnover of Ankleshwar site.
Total 6 Intermediate Production Blocks & 8 Nos of PP areas.
Basic API Products are Atorvastatin Calcium, Pregabalin, Amlodipine Besylate, Etoricoxib, Valsartan, Desvenlafaxine, Pantoprazole, Tramadol HCl, Teneligliptin.
Job Responsibilities:
Manufacture quality products as per the requirement of the customers and ensure timely delivery for the dispatch of the product in close coordination with Marketing and Logistics department.
Review and study product parameters, reduce time cycles, improve yields, reduce energy conservation, bring down product cost, increase profitability and ensure optimum utilization of the plant capacity.
Coordination with QA for Audit preparation, visits, operation plans and document closure. Coordination with Engineering department for daily PM & maintenance related work. Coordination with QC for daily analysis priority.
Taking care of ISO 9001, OHSAS audits. Also taking care of GPCB, Factory inspections.
Taking care of inventory control of raw material, intermediates and finished products.
Reducing production cost by implementing right first time (RFT)/ failure reduction with effective root cause analysis and CAPA implementation.
Coordinate with EHS department for achieving zero incident/ accident. Closing all the near misses observations in timely basis.
Maintain safety norms, as in force, usage of required & appropriate PPEs, Permit systems and implementation of various safety guidelines/ norms from time to time.
Administration of total department to develop good teamwork, maintain discipline, motivate employees for long term period.
Work in close co-ordination with TT/ R&D team for new product validations in plant.
Monitoring production, technical evaluation, analyzing processes & debottlenecking of the processes to increase its throughputs thereby reducing overheads of that products.
Strengthening cGMP system as per ICHQ7 norms in the plant to reduce customer complaint & improving standard of the plant.
Waste reduction at source / Water conservation / COD & hydraulic load reduction. Air pollution controls. Solid waste reduction
Coordinating training programs time-to-time to enhance the skills of the subordinates and as a result gain improved productivity.
Driving innovation scheme in production block to enhance moral & competitiveness of the production team.
Complete evaluation to MIS report
On monthly basis with action plan for improving product usage ratio/ overhead reduction.
Heading team for improving SOLVENT recovery of all the products.
Take leading part in fixing budgetary exercise in every year, to fix norms of the products based of marketing volume.
Team member CAPEX TEAM, who work to get sanction of the CAPEX budget for the plant for increasing the efficiency of the plant by providing relatively small change in the hardware, new technologies & its implementation.
Heading Team which includes R&D, PDL, engineering persons for day-to-day problems or improvement in regular products.
Reviewing quarterly performance of plant with respect to production, quality, safety, cost savings projects, profitability, maintenance/ break down, utility consumption, waste generation.
Experience of implementation of various tools such as Six sigma, JIT, Kaizen, Quality management, Lean manufacturing.
Labor related issue solving through meeting with HR department.
Responsible for achieving budgeted norms of RMC, Consumables.
Responsible for Capacity enhancement projects.
6 section plant heads reporting to me. (Staff: 110 No)
Reporting to Sr. GM-Operations.
OTHER ORGANIZATIONAL EXPERIENCE:
5] CADILA PHARMACEUTICALS LTD., ANKLESHWAR (GUJARAT)
Worked as Production Head from 11th August, 2014 till August 2017
Ankleshwar site is USFDA, ISO 9K, 14, 18K, TGA, PMDA (Japan), WHO (Europe & Geneva), Health Canada certified organization.
310 Cr. Turnover of Ankleshwar site. Out of which MPP-II Plant contributing 70% of turnover i.e. 216 Cr.
Acting as Head of Department for Production (MPP-II Plant).
Basic products are chemical intermediates such as Chlorhexidine Base, ChlorhexidineGluconate and chemical such as Nebivolol intermediates, Venlafaxine intermediates and Nateglinide intermediates.
Basic API Products are NebivololHCl,, Cilostazol, Sildenafil HCl, OndansetronHCl, Carvedilol, Nateglinide& Venlafaxine HCl.
Achievements:
1.Capacity enhancement of Chlorohexidine base from 12 MT to 25 MT.
2.Effective CAPA for failure batches. Eg. Netiglinide
3.RFT for many products achieved.
4.Contamination issues resolved for Cilostazole with new PP area designing & modification.
OTHER MIDDLE MANAGEMENT EXPERINCE (May-2002 to June-2014)
7] JUBILANT LIFESCIENCE, VILAYAT GIDC, BHARUCH (GUJARAT)
8] SI GROUP INDIA LTD, LOTE MIDC (MAHARASHTRA)
9] GLAXOSMITHKLINE, THANE (MAHARASHTRA)
10] ORCHID CHEMICALS & PHARMACEUTICALS LTD,AURANGABAD (MS)
11] DAI ICHI KARKARIA LTD, HYDERABAD (AP)
EDUCATIONAL QUALIFICATION:
Bachelor of Engineering - Chemical (2001): Pune University (60.40%)
Higher Secondary Certificate (1997): Pune University (76.67%)
Secondary School Certificate (1995): Pune University (84.57%)
PERSONAL PROFILE:
Date of Birth : 10th May, 1979
Marital Status : Married (2 Sons)
Sex : Male
Languages Known : English, Hindi, Marathi and Punjabi.
Present CTC : 24 LPA
Expected CTC : 40 LPA
NOTICE PERIOD : 1 Month
I hereby declare that all the above information is correct to best of my knowledge and belief.
(Guruditsingh Vadhwa)
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