To work with full dedication in a challenging atmosphere, while adding some significant values to the organization and to gain professional skills while working with support of competent peers and guidance leader which will further enhance my career ambition of rising to pinnacle of success.

Bachelor of Pharmacy

Graduated, June 2009 ASBASJS Memorial college of Pharmacy Bela,

Ropar Punjab, India.

10+2

H.P.B.O.S.E. DHARMSHALA (H.P.)

10th

H.P.B.O.S.E. DHARMSHALA (H.P.)

Bachelor of Pharmacy with 9 Year 8 Months rich Experience in Tablet and Capsule manufacturing.

Currently working as Section Manager Production at HOVID BERHAD, IPOH MALAYSIA from April 2019 to till Date.

Worked as Sr. Executive Production at UNICHEM LABS LTD, BADDI from May 2013 to March 2019.

Worked with “LUPIN LTD.” Jammu in Production as Officer from Aug. 2011 to Apr. 2013.

Worked with “FDC LTD.” Baddi in Production as Officer from Apr. 2011 to Jul. 2011.

Worked with “ASSOCIATED BIOTECH PVT. LTD.” Baddi as Production Chemist in Production from Aug. 2009 to April 2011.

JOB PROFILE & RESPONSIBILITIES

To monitor all production activities like Granulation, Compression and Coating as per requirement and w.r.t. quality prospective and production demand.

Execution of monthly production plan as per APSR & streamline work processes of production and cleaning activities of all equipments and areas.

Ensure the engineering activities such as Preventive maintenance, Routine & breakdown maintenance, Calibration, Equipment & Area validation in Production area are being carried out as per the schedule.

Implementation of Current Good Manufacturing Practices in the Production area to meet the requirements of Company and International Regulatory Agencies.

Active involvement and facilitation of new product introduction on manufacturing site.

Successful introduction of more than 20 products with site variation filing in coordination with RA and R&D.

Successfully handled technology transfer of 30 products to Sikkim manufacturing site and reduces the process waste, insufficiencies and improve productivity.

Ensure and execute tasks strictly following cGMP, Quality, Safety and SOP compliance.

Identify potential issues associated to products, processes, quality, safety and work on proactive internal measures to prevent incidents.

Lead an investigation team for incident investigation with good report submission as per regulatory standards and provide guidance to team members.

RM management in coordination with purchase so that monthly plan shall not hamper.

Successful completion of various cost saving and improvement projects.

Data preparation and execution for Deviations and Change Control handling.

Data Management in MINITAB.

Actively involved in Process validation of new products as well as existing products.

To carry out all SAP activities related to Job Profile.

Optimum utilization of resources to maximize the output.

Document Preparations including market specific MPR/BMR preparations and review, SOP’s Preparation, Protocol preparations etc.

To enforce and maintain high degree of morale, discipline amongst the team.

To ensure the conformance of system and work practice with the standard operating Procedure based on cGMP and documentation.

To maintain 5S concept on the shop floor activities.

Product and process monitoring and preparation of OEE data & machine JBS.

To maintain the inventory of change parts and spare parts of various manufacturing machines by coordination with purchase Dept.

Handling of production manpower & maintain their schedules including Trainings and production activities.

To maintained the all Dept. documents and compliance of internal/external inspections.

All time readiness of manufacturing area for Inspections and audits.

To ensure that the subordinates are adequately trained for the job assigned.

Equipment’s qualification and CAPEX w.r.t. to DQ, IQ, OQ, PQ.

Develop manufacturing strategies and focus on competitive cost in the manufacturing procedures and SOP.

Drive and meet company’s KPI set by improving day to day working standards.

Perform non-conformance handling such as CAPA, investigations and root cause analysis.

Excellent communication skills inter Dept. and intra Dept.

Good knowledge of SAP transactions.

Maximum utilization of Machines, manpower & Time using OEE implementation.

Reduction in the number of manpower by implementing automation & increase in the output day by day.

Knowledge of cGMP and regulatory inspections.

Overall manufacturing area handling with focus on quality and productivity.

APSR handling for PPIC, RM and FG management.

MPR/BMR, JBS preparations.

SOP’s preparations with zero gap in terms of SOP vs actual.

Deviations and Change control handling.

Handling of QMS activities like QRM, investigations and failure /OOS handling.

Technology transfer of new products to site.

Key member of validation team and leading manufacturing area.

Technical assistance to machine operators regarding the handling of various critical machines. Like GEA RMG, FBP GEA, Pam Glatt, AF 25T, AF 90T, GAC 900/1200, Xiaolun auto coater and compression machines Fette P2020, Fette P3030, Bosch capsule machine and Sensum automated inspection machine.

A quick learner with abilities to work in a team environment and work under strict deadlines.

Smart & Hardworking working spirit.

Dedicated towards work & result oriented.

MHRA

ANVISA

MCC

EU

PIC/S MALAYSIA

RUSSIA

WHO GENEVA

FDA

UGANDA

NIGERIA

TANJANIA

ZIMBABWE

ETHIOPIA

KENYA

ACHIEVEMENTS AND PROJECTS HANDLED

Successfully Faced and cleared Various Audits Like MHRA, ANVISA, PIC/S MALAYSIA, MCC, RUSSIA, WHO GENEVA, UGANDA, NIGERIA, TANJANIA, GHANA and KENYA AUDIT.

Successfully participated on project EBR (Electronic Batch Manufacturing Record generation) With LUPIN limited.

Successfully participated and Achieved Project SOP’s Simplification, Project Utkarsh, Leader Plus and Project rise.

Software handling: SAP (ERP), BAAN, LMS, APSR, MINITAB, LIMS and other related software’s.

OTHERS: MS OFFICE: WORD, EXCEL, PPT etc.

Hindi

English

Punjabi

Father’s Name: Mr. Joginder Singh

Mother’s Name: Mrs. Kanta Devi

DOB: 11 July 1988

Gender: Male

Marital Status: Married

Permanent Address: Vill. Dilwan P.O. Diara, Tehsil Amb,

Distt. Una (H.P.) 174316, India.

DECLARATION

I, Rakesh Kumar, hereby declare that the information contained herein is true and correct to the best of my knowledge and belief.

Rakesh Kumar Place:

Phone: +601*********, +919*********

Email: ac9rum@r.postjobfree.com

Pharmaceutical Manufacturing Professional

RAKESH KUMAR

CAREER OBJECTVE

EDUCATION

PROFESSIONAL QUALIFICATIONS

CAREER HIGHLIGHTS AND WORK EXPERIENCE

SKILLS

AUDIT EXPOSURE

COMPUTER PROFICIENCY

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PERSONAL DETAILS

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