Management Plant

M. Pharmacy Graduated, ****-****

J.K.K.Natarajah college of pharmacy, Salem Marks: 70.70%.

Dr.M.G.R Medical university, Chennai Division: First class

B. Pharmacy Graduated, 2002-2006

S.B College Of Pharmacy,Sivakasi Marks: 71.00%

Dr.M.G.R Medical university,Chennai Division: First class

HSC Graduated, 2001-2002

Govt.Higher secondary school Marks: 83.00%

kallamanaickerpatti, Tamil Nadu. Division: First class with distinction

S.S.L.C Graduated, 1999-2000

Govt.Higher secondary school Marks: 85.00%

kallamanaickerpatti, Tamil Nadu. Division: First class with distinction

Shop floor management (Production planning, Target oriented line balancing, Co-ordination with cross functions)

Productivity management and Mfg. Excellence (OEE, Cycle Time, JIT, Process improvement, Routings, budgeting)

New products & Projects (Site transfer, Process Validation, Equipment’s Qualification)

Cost Of Goods Improvement Lean Management (alternate vendors validation, SMED, 5S, VSM, TPM)

Product trouble shooting (Granulation, Compression, Coating, packing, pellets coating, antibiotics,dry syrup and sterile manufacturing)

Manufacturing Investigation (OOS, OOT)

Quality management (Handling change control, Deviation, and market complaints)

Audits & compliance (Manufacturing Compliance)

Documentation (SOPs, PVP, PVR, RA, BMR, BPR)

Training & Development (Technical training)

Team lead and people management (Appraisal management, Leave Management, Shift scheduling)

Amlodipine and Atorvastatin calcium tablets validation activities successfully completed in Dr.Reddy’s for US market.

1.MOH Industrial approved Pharmacist from OMAN government, OMAN, Muscat.

2.Global innovation awards for process improvement from Cipla head office.

3.Certification of appreciation award from Dr.Reddy’s for achieves the highest output with zero quality incidents.

Sl. No.

Name of the Organization

Designation

Department

Duration of work

01

Hyderabad.

Deputy Manager

Production & QMS

Dec. 2017 to till date

02

Sun Pharmaceutical Industries Limited (Mohali SGO-Unit1)

Team leader

Production & QMS

May 2016

to Dec.2017

03

Oman pharmaceutical Product Co.L.L.C(ZYNOVA)-Oman

Senior Executive

Production

Dec.2014 to Apr 2016

04

Dr. Reddy’s Laboratories Ltd, Generics, Hyderabad

Senior Executive

Production

June 2012 to Dec.2014

05

Cipla Ltd, Indore SEZ

Management Staff

Production

July 2010 to June 2012

06

Astalife,Pondicherry

Officer - Production

Production

Sep 2006 to June 2010

Over all Job responsibilities:

1.Shop Floor Management

1.1Monthly planning, weekly& daily review of production planned Vs actual for 100% schedule adherence.

1.2Target oriented manpower-planning, line balancing with products with multiple machines validation for flexi planning.

1.3Coordination with cross function for smooth running of production operations.

2.Productivity management and Mfg. Excellence

2.1 Daily follow-up of Overall Equipment Efficiency.

2.2 Ensure to achieve least Cycle Time by following JIT & without affecting OEE.

2.3 Brainstorming with team for Process Improvement.

2.4 Take part with controlling & accounts departments for routings & budgeting.

3.New Products & Projects

3.1.Assist in transfer process from mother plant, Initiate manufacturing activities with mother plant, make schedule batches, make reports, seek approval from mother plant, validate manufacturing and ensure release as per plan to successfully transfer products to the manufacturing site

3.2.Reviewing the Master manufacturing dockets, Tooling & others machineries specification. Capacity calculation & others risk analysis pertaining to process & products safety.

3.3.Preparation and review of Risk Assessment, Qualification and Validation documents i.e. PQP, PQR

3.4.Execution of Validation and Qualification activities along other responsible department

3.5.Execution of FAT, IQ, OQ & PQ for new equipment.

4.Cost Of Goods Improvement Lean Management

4.1.Responsible for implementation of LEAN (SMED, VM, VSM) a MANAGEMENT tool for all type of industries that help a lot for survival of industries even at the time of crisis. (A tool for producing product with least cost & high quality that’s reduced the NVA cost.

4.2.Alternate vendors validation

4.3.SMED a tool for reduction of change over time to achieve just in time production.

4.4.Implementation of 5S, VSM, TPM

5.Product trouble shooting

5.1Hands-on experience on trouble shooting in mfg. process of Granulation, Compression, Coating, packing, pellets coating, antibiotics, dry syrup and sterile manufacturing.

6.Manufacturing Investigation

6.1 Preparation and review of process investigation report for OOS, OOT pertaining to IP, SFG, FP & Stability.

6.2 Root cause analysis, Identification of CAPAs, CAPA follow up and implementation of it.

6.3 Process Engineering, design of Experiments, engineering protocol, batch execution and report

6.4 Risk assessments for legacy products, phase gate report review for batch scale up.

6.5 CPk ppK evaluation for CMA, CPP & CQAs.

7.QMS:

7.1.Management of change control, logging change control for execution of various activities on the shop floor and closing them after proper execution of activity

7.2.Preparation of Risk assessment to analyze risks involved in implementing the change

7.3.Closure of Change control after successful implementation

7.4.Logging of deviation into system after identification and consulting higher authorities

7.5.Deviation investigation to identify the root cause using various tools (5 whys, Swiss cheese, fish bone/ 6M techniques)

8.Audits & Compliance:

AUDIT FACED: MHRA, USFDA, ANVISA, WHO, TGA & GLOBAL QUALITY AUDIT OF OMAN ZYNOVA GROUP

8.1.Tracking of audit compliance and updating and compliance status to higher management

8.2.CAPA initiation, follow up, training on compliances & CAPA

8.3.Protocol based study and compliances to audit observations through system up-gradation

8.4.Auditing 3rd party, supplier audit for RM, PM as a co auditor.

8.5.Audit report compilation and feedback to audited site.

8.6.Lead role in regulatory audit & facilitate plant round to auditors.

9.Documentation

9.1.Preparation of departmental SOPs, Preparation of Batch Records, validation documents, Risk assessment.

10.Training and development:

10.1.Training to shop floor personnel on GMP, GDP, SOP & Technical training, HSE (machines & products safety), CAPA

11.Team leading& People management

11.1 Preparing the monthly report on quality & productivity.

11.2 Managed shift schedules, LMS & appraisal of reportee & monitoring their performance.

11.3 Handled trade union workmen at different work for cent percent capacity utilization.

11.4 Conducting daily MEETING with team to discuss issues related to safety, quality, delivery, cost and involvement.

WHO Geneva

USFDA

EU GMP

TGA

MHRA

MCC

UGANDA

ANVISA

MOH

Product Development Laboratory.

Production and production planning.

Technology transfer

Production compliance team

Contract manufacturing site audits

Computer Basics, MS Office, MS word, Excel & Power point.

Internet Operation etc

ERP, SAP and IMS.

English

Hindi

Tamil

Telugu, Kannada, Malayalam

Playing cricket

Watching Tennis

Team leading abilities.

Audit facing abilities.

Willingness to accept the new challenges

Father’s Name : Mr. S.Paluchamy

Marital Status : Married

Date of birth : 03-04-1985

Nationality : Indian

Gender : Male

Address : 121/2, North Street, Vembakkottai, Edhirkkotai Post, Sivakasi Taluk,

Virudhunagar District – 626131

References:

Mr.G P Chaudhary- (Vice president, Hetero unit-3) Hyderabad. Contact: +91-917*******

Mr. Gurumukh Tejwani, -GM (Mylan Labrotories Ltd.) Contact no. 91-957*******

Dr.Parag Das chitta,Sr.VP-Technical Operations, (Oman pharmaceutical products co LLC) Contact.no. +968-********

Declaration

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

Hyderabad

Marichamy.p Date:

Production & Process excellence specialist (Sterile & Non-sterile)

Passport No.P3806647

Marichamy. P

CAREER OBJECTIVE

WORK EXPERIENCE

12+ Years

To obtain a position that will enable me to use my production and research skills, strong educational background, and ability to work well people.

AGE

34

Audits faced

Areas of interest

Computer Proficiency

Personal Interests

Personal Strengths

Contact this candidate