Manager Machine

CURRICULUM VITAE

ROOHULLAH FAISAL

Current Location

JNPC pharma city, Visakhapatnam

Andhra Pradesh, India

Mobile: +91-849*******, 829-***-****

E-mail: **********@*****.*** / ***************@*****.**

OBJECTIVE:

“Looking for a challenging position in a leading edge industry where I can utilize my skills and disperse my vision, from where I can emerge a valuable asset for the industry.”

PROFESSIONAL PROFILE:

Total 8 years’ experience in: - Production Injectable (Sterile Formulation) department.

Comprises: - Sterile Formulation: – Liquid, Lyophilization and dry powder injection.

Area Expertise:-Manufacturing, Filling, Packing, Operation, planning and Documentation, Area related SOPs, Protocols, BMR, BPR, Change control, Deviations etc.).

DOSAGE FORM HANDLED: Injectable-Oncology (Liquid and Lyophilized Products), Carbapenem Antibiotics (Dry powder injection), Ophthalmic, Nasal Spray.

PROFESSIONAL SKILLS:

Able to work an individual and operate all process of sterile production Facilities like, Filling and packing online documentation and submission.

Equipments Handled like, Vials filling closing and sealing machine (Mar, B+S, IMA), STEAM STERILIZER (Pharmalab), Lyophilizer (BOC EDWARD, Tafflon), Tunnel (Macofar, B+S, IMA), Vial washing machine (Romaco, B+S, IMA, Truking, Bosch), DHS (Pharmalab), Leak testing machine (Wilco), Labeling machine (Axus, Packleader), etc.

Independently manage the production activity and manpower, cGMP, Machine operation training, established the system and workout for its smoothness.

ACHIEVEMENTS:

Actively participated for Validation of Leak testing machine (liquid online leak testing machine make Wilco), Steam sterilizer (Pharmalab), Qualification and validation of Tunnel, Vial washing, vial Filling machine.

Successfully completed the Media fill batches for sterile formulation.

Appreciated for SETUP COMPUTERIZED SHIPPER LABEL CODING (Replaced with manual coding on shipper Label) to give good impact of shipper label.

Attended training for worker handling and got Training certificate of “CENTRAL BOARD FOR WORKER EDUCATION”.

Appreciated for “HIGHEST PRODUCTION OUTPUT IN THE SHIFT”, and maintaining consistency QUALITY OF PRODUCT WITH ONLINE DOUCUMENTATION.

Appreciated for setup: - TOP AND BOTTOM LABELING MACHINE SETTING (Axus Labeling machine) for all type of pack size (combo pack BFS/FFS Cards).

TECHNICAL EXPERTISE:

1)Aseptic process handling: like Batch Manufacturing and filling operation, and problem shooting and completing the work on time.

2)Good operating knowledge of an equipments uses in process, and trained to sub-ordinate effectively.

3) Actively participating in production trouble shooting, process non-compliance investigation, deviation, change control etc.

4)Preparation of URS for new system and handling of vendor meeting.

5)Able to do the qualification of equipments and area, Challenge the system, process in different mode by which we can validate its performance.

6)Always looking for a valuable plan for better productivity, cost saving and better quality.

7)Thorough Knowledge of Clean Room Operations and Aseptic Process Qualifications.

8)Have Knowledge on various document Preparation like SOPs, Qualification Protocol, Media fill Protocol, Batch Processing Records etc.

9)Have better exposure of Audit like EU –GMP, MHRA, USFDA (Preparatory) ANVIS, and MCC etc.

STRENGTH:

Ability to work as an individual, as a part of team and as a team leader, Capable of making good decisions.

Always looking for challenging work, and willing to learn new system and its execution.

Capable to work at varying situation, Handling of machines and managing the work & manpower.

Believe in open discussion, Honesty and smart working, leading from the front to resolve the problem

PROFESSIONAL QUALIFICATION:

B.PHARM from SSCP College, Tumkur. Rajiv Gandhi University of Health Sciences, Bangalore in 2006.

MBA with two specializations: i.e. Operational & Production management, pharmacology management from National Institute of Management, Mumbai in 2008.

ACADEMIC PROFILE:

Tenth Class from BIHAR SCHOOL EXAMINATION BOARD PATNA, BIHAR in 2000.

Twelve Class from BIHAR INTERMIDIATE COUNCIL PATNA, BIHAR in 2002.

ORGANIZATIONAL EXPERIENCE: CURRENT EMPLOYER:

Hospira Healthcare India Pvt. Ltd, Visakhapatnam, Andhra Pradesh, India.

Designation: - Research Scientist (Assistant Manager), Manufacturing Scientist and Technology.

Since: - April 2014 to till date.

Reporting to: - Director (GM) Manufacturing Scientist and Technology.

Manufacturing Science and technology makes a bridge between US facility to receiving facility, where product are getting transfer from sending site to receiving site through technology transfer process. We are take care the product specific requirement until the complete execution. Based on the scale up; fix the specification of product.

JOB PROFILE: (Liquid Injection)

Responsible for Product Formulation Development from sending site receiving site.

Preparation of document like Tech transfer Protocols etc.

Product execution and Troubleshooting during the execution.

Execution Trial, scale up, Exhibit batches.

PREVIOUS EMPLOYER:

1)Aurobindo Pharma Limited, Hyderabad, Andhra Pradesh, India.

Designation- Sr. Executive, Production (Sterile Formulation)

Since- Jan 2013 to Mar 2014.

Reporting to- Sr. Manager (Production).

Company Profile- Aurobindo Pharma Ltd. Being a sterile manufacture of injectable product since 1992. Aurobindo Pharma Limited is one of the leading manufacturers of life saving anti-biotic bulk drugs as well as formulated drug in India and abroad with excellent track record of profitability and growth. The Company is one of the largest manufacturers of Ampicillin and Cloxacillin. Aurobindo currently manufactures three types of drugs including cephalosporin-based formulations, drugs for gastroenterology, antibiotics and pain-related products.

JOB PROFILE: (Liquid Injection)

Responsible for Execution of production planning, cGMP implementation, Execution of validation of area, equipment, cor-ordination with concern department to execute the activity within the timeline

2)UNIMARK REMEDIES LTD., Ahmadabad, Gujarat, India.

Designation- Sr. Officer Production (sterile formulation).

Since- Oct-2011 to Jan 2013.

Reporting to- Manager.

Company Profile: - It is Indian based company having injectable sterile API manufacturing on small as well as large volume in domestic and Export as well. Moreover, new Expansion of plant for sterile API and formulation for US market, plant and system designed for regulatory market. In these we are actively participating to compliance his all aspects.

JOB PROFILE: Sterile Formulation (Dry powder injectables,Carbapenam Antibiotics)

Responsible for Production planning and activity towards the monthly planning, Managing manpower, shift handling, Documentation, and process.

Preparation and execution of validation document like, SOP, IQ, OQ and PQ protocols of the following system.

A)HVAC system (Citizen industries)

B)Vial filling machine (Bausch+Strobel)

C)Depyrogenation Tunnel (Bausch+Strobel).

D)Autoclave (Pharmalab)

E)Vial Washer machine (Bausch+Strobel).

F)Preparation of User Required Specifications (URS) for new facility.

Responsible for preparation of Sops, protocols, BPCR of the production formulation and its execution as well. Strictly follows cGMP on shopfloor.

Responsible for manage the manpower and allocation as per daily activity plan.

3)FRESENIUS-KABI ONCOLOGY LTD.UNIT-II (USFDA, MHRA, WHO approved.) (Formally Known Dabur Pharma Ltd., Baddi, Himachal Pradesh, India)

Designation- Production officer, (Sterile Production)

Since - FEB. 2010 to Sep.2011.

Reporting to - Manager and AGM Production

Company Profile: - it is German based company, having Export markets in many countries.

JOB PROFILE: Oncology (liquid filling and lyophilized Products)

Responsible for batch planning and preparation for filling with online documentation as per plan.

Manpower handling and work allocation with respect to planning.

Responsible for team management to achieve the monthly goal, and to minimize the problem.

Responsible for meat the requirement of aseptic area with technical support.

Actively participated in many validation activities and done validation of autoclave.

Responsible for manpower planning and shift planning to achieve our production planning.

Independent handling of overall batch, preparation, manufacturing and filling.

Preparation of documents like Batch Production Record (BPR), Batch Filling Record (BFR) Standard Operating procedures (SOPs).

Daily Production report and downtime compilation and plan for zero downtime.

OPERATIONAL EXPERTISE:

VIAL WASHING MACHINE (ROMACO), TUNNEL (MACOFAR), TERMINAL STERILIZER (FABRIC), FILLING MACHINE (MAR), cRABS (Sterilline)

STEAM STERILIZER(Autoclave) (FABRIC), EXTERNAL DECONTAMINATION MACHINE (MAR), LABELLING MACHINE (PACK LEADER) and LYOPHILIZER(BOC EDWARD)

4)CIPLA LTD. (USFDA, WHO approved), Kumrek, Rangpo, East Sikkim, Sikkim. INDIA.

Designation- Management Staff, (Production)

Since JULY- 2009 to FEB. 2010

Reporting to Department head.

Company Profile:-It is Indian based group compiling all regulatory requirements, having largest domestic market in India as well as Exporter in many countries. They have latest technology and new system for compete the market requirement with best quality.

5) PROMED EXPORTS PVT. LTD. (WHO, EUGMP approved), Nalagarh.Himachal Pradesh. INDIA

Designation- Jr.Executive Sterile Formulation (Production).

Since January 2007 – JULY- 2009

Reporting to Asst. Manager.

Company profile: Promed Exports Pvt. Ltd. is one of the leading manufacturers and exporters of pharmaceutical formulations. It has been in this field for more than 15 years, certified organization From ISO 9001:2000, WHO and EUGMP.

To comply with USFDA, EMEA, ANVISA, MHRA guidelines.

Designed as per cGMP requirements.

Dedicated to aseptic filling as well as terminal sterilization of small volume parenterals.

Flexibility to produce containers of various shapes & sizes using latest BFS (FFS) technology.

Capability to manufacture Solutions as well as Suspensions.

JOB PROFILE: Same in the Promed and Cipla :( Sterile Formulation, Ophthalmic and Nasal)

Execution of Daily & Weekly Production Planning with seniors against Material Availability & Priority Basis.

Responsible for validation of leak testing machine and SOP’s for packing equipments.

Preparation of documents like Batch Production Record (BPR), Batch Filling Record (BFR) Standard Operating procedures (SOPs).

Always looking for “Best Quality greater Output On-time every time”.

OPERATIONAL EXPERTISE:

BFS (FFS- Blow/Form Fill Seal) machine (Weiller)*CAM Cartooning Machine (CAM). Cartooning Machine (IMA)

*Capping machine (KAPS ALL, Groninger) and *Leak testing machine (WILCO), Inkjet printer DOMINO and *HS jet TCU CON-DOT printer, HRIZONTAL and TOP-BOTTOM labeling machine (AXUS), Check-weigher (ANRITSU), *Auto-pack bundling & shrink Wrapping (45TL).

AUDIT FACED:

W.H.O. and Internal audits.

EUGMP

MHRA, and re-audits ISO 9001:2000

ANVISA, Brazil. USFDA.

COMPUTER SKILLS:

Basic knowledge Microsoft-OFFICE, power point, Microsoft paints,

SAP database.

INTERESTS:

Listen music, travel, surfing net to search and learn new technology.

PERSONAL DETAILS:

Father Name : Mr. Abdul hai

Permanent Address : Vill&post: Khairi Banka,

Via: Keoti Runway

Distt.: Madhubani,

State: Bihar-847122

Date of Birth : 30 / 11 / 1985

Marital Status : Married

Religion : Muslim

Languages Known : English, Hindi, and Urdu

Passport no. : G0351978 (Valid till: - 27/11/2016)

DECLARATION:

I hereby declare that the information given above is true to the best of my knowledge.

Place: Date: (ROOHULLAH FAISAL)

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