RAMAJAYAM EMAYAVARAMBAN

** ********* ****** * **************, Tamilnadu l INDIA.606702

Phone: +91-971******* l adk6gy@r.postjobfree.com

Professional Summary

Accomplished Senior Executive driven to improve the Quality systems and successful audit clearance.

Specializing in the Pharmaceutical chemistry and serving pharma industry for 9.5 year in Quality assurance department.

Registered Pharmacist Licensed by Pharmacy council of INDIA.

Lifetime Permanent member of Indian Pharmaceutical Association (IPA)

Competent Technical Staff to carry out Quality operation, authorized by Govt. of INDIA

Skills

Quality Assurance

New product Launch

Operational Excellence

Creative Team Leadership

Problem Solving

Decision Making

Gap analysis

Flexibility

Employment Record

DESIGNATION: Senior Executive PERIOD: 06/2015 to till date.

EMPLOYER: Strides Pharma Science limited (multinational company involved in development & manufacturing of Pharmaceutical products, approved by FDA, MHRA, etc.)

RESPONSIBILITIES:

Quality Management:

Initiation, assessment, review, approval and closure of change control, deviation, CAPA.

Key member of root cause investigation team, OOS and OOT.

Periodic monitoring and closing of QMS events.

Trend analysis of QMS events quarterly and annually.

Escalation to senior management on highlights and area of improvements required.

Prevent the recurrence of deviation/ non conformances.

Front line representative in Customer and regulatory audits

Process Validation: Preparation and review of process validation protocols and reports, Sampling of validation batches, Application of statistical tools in validation, Continuous process verification

Batch Documentation: Review of master and executed batch records in compliance to SOP and regulatory guidelines.

Cleaning validation: Identification of worst case molecule. Calculation of MACO, Preparation and to update cleaning validation matrix, validation of cleaning procedures.

Quality Risk Assessment: Analyze the risk involved in each manufacturing operation in compliance to

ICH (Q9), preparation and review of Risk based prioritization plan.

Site Transfer and Development products: Development QA lead, review and approval of MFR, MPR inline with dossier. Filing and deficiency response. New Product introduction & commercial launch

ACHIEVEMENTS

Implemented the Lean six sigma concept in manufacturing operations.

Implementation of reduced testing program based on trend and Risk assessment.

Identified process inefficiencies through gap analysis.

Streamlined operations to maximize business efficiency and profits.

Managed team of six direct reports responsible for on-going product optimization.

Implemented simplified batch records with focus on quality and regulatory aspects.

Managed internal and external audit.

Successful clearance of USFDA & MHRA audits.

DESIGNATION: Executive PERIOD: 07/2014 to 06/2015

EMPLOYER: Softgel Healthcare Pvt limited (company involved in manufacturing of Pharmaceutical products)

RESPONSIBILITIES:

Process Validation: Preparation and review of process validation protocols and reports, Sampling activity.

Standard Operating Procedures: Preparation and Review of SOP’s in compliance to regulatory guidelines.

Equipment Qualification: Installation, operational and performance qualification of

Dispensing booths

Air Handling units

Weighing balances

CVC bottle packing line

ACHIEVEMENTS:

Co-ordination in Successful clearance of audits,

INVIMA (Columbia regulatory)

EuGMP

BRC (British Retail consortium)

DESIGNATION: Management Trainee PERIOD: 11/2011 to 06/2014

EMPLOYER: CAPLIN POINT LABORATORIES limited (company involved in manufacturing of Pharmaceutical products)

RESPONSIBILITIES:

In-process Quality assurance of Tablets, Capsules, Liquid orals.

Monitoring of manufacturing activities

Routine sampling of commercial and development batches.

Cleaning validation swab and rinse sampling.

Line clearance for batch manufacturing.

ACHIEVEMENTS:

Co-ordination in Successful clearance of WHO GMP audit.

Technology

SOFTWARE:

DMS (Document management system), Trackwise, SAP, MS Office (Word, Access, Excel, PowerPoint), e- BMR.

Education

DEGREE: MASTER OF PHARMACY,2011

UNIVERSITY: The Tamil Nadu Dr. M.G.R. Medical University, CHENNAI, INDIA.

SPECIALIZATION: Pharmaceutical chemistry

THESIS: SYNTHESIS AND CHARCTERIZATION OF 1,3,4 – Oxadiazoles.

Graduated with 83 %

DEGREE: BACHLEOR OF PHARMACY,2008

UNIVERSITY: The Tamil Nadu Dr. M.G.R. Medical University, CHENNAI, INDIA.

SPECIALIZATION: PHARMACY

THESIS: DIABETES MELLITUS.

Graduated with 71 %

Training

Lean Six sigma methodologies (Green belt) Certified

Personal Information

Date of Birth: 18/02/1987 Nationality: INDIAN

Languages Known: English and Tamil (Fluency: Excellent)

Passport number: Z3168966

Certification

I, the undersigned, certify to the best of my knowledge and belief this CV correctly describes my qualifications and my experience.

I understand that any willful misstatement described herein may lead to my disqualification or dismissal, if engaged.

END

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