Project Manager

Validation Manager

"Possess Perfect blend of both pharmaceutical engineering and process

knowledge"

o 10 years of hands-on technical and management level experience:

Within major segments of the regulated industries such as

pharmaceutical and biotech. Fairly involved in medical device,

cosmetics and FMCG industries also.

o Serving with various business units from production, quality

assurance, process optimization, validation, GMP compliance, project

management, engineering, training and development.

o Validation: Experienced in validation project management, consisting

of multiple tiered complex projects with high visibility, aggressive

schedules with significant negotiation to balance the needs of

multiple stakeholders and achieve specific business goals or

objective.

o Hands-on ability in the production of these formulations: tablet;

capsule; liquid oral (syrup, suspension); lozenges; topical

preparations (creams, lotions, pastes, ointments, balm); cosmetics

(lip guard, shampoos, face wash gels / creams etc)

o Extensive knowledge in industry standards: National and international

regulatory requirements along with a thorough knowledge in the process

of implementation and audit of these standards. Excessively performed

external GMP audit and internal ISO audit

Other competencies include: ---

Conceptual design study Validation project management

Equipment costing Establishing QA systems

Developing Validation Master Plan Preparation, review and

and Project validation plan implementation of SOPs.

Prepare Tender / user requirement Conducting validation workshops

specification / datasheets for

process equipments and utility

systems

Preparation of Technical bid Conducting training programs and

analysis workshops for guidance, preparation

and implementation of cGMP

Risk analysis and mitigation for Contribution in proposal support,

equipments, clean utilities and pre-sales activities.

facility

Qualification of equipments / Conduct GMP and mock audits

clean utilities: Prepare / review

/ execute DQ,IQ & OQ

Control of FAT / SAT GAP Analysis

Summarize project validation Implemented and periodically

report conduct internal audit for ISO9001

Wide exposure to the international business environment, ease to

communicate and interact with global organizations & people, traveled all

over Germany, Denmark, China, Srilanka and Qatar on the business deals

Work Experience

Manager - Validation & cGMP Compliance - M/S NNE Pharmaplan India Ltd -

June'05 to Present

The Company is one of the worlds leading Consulting Engineering Company

providing services to the pharmaceutical and biotechnological industries..

The company supplies customer-oriented qualified solutions characterized

by GMP competence. It is one of its kinds in the field of Pharma

consultancy, which is basically a part of Denmark organization working in

India.

. Accountable for conceptual design study.

. Preparation, review and execution of validation protocols.

. Experienced in end to end project management starting from requirement

gathering, knowledge transfer, project plan preparation, identifying

the deliverables, project documentation, client communication, ramping

the team, team building, team motivation, project execution, and

project closing and handover.

. Conducting validation workshops and GMP trainings.

. Making presentations to clients, carrying out GMP and Mock audits

and preparing gap analysis for the up gradation of the facility.

Projects Accomplished

< Dabur Pharma Ltd - Baddi (Non cytotoxic OSD, Cytotoxic OSD and

Cytotoxic Injectables)

< Reliance Pharmaceuticals Limited - Jamnagar (OSD and injectable plant)

< Zhejiang Hisun pharmaceuticals -China

< Otto pharmaceuticals - Indonesia (Beta lactum and Non-Beta lactum

plant)

< Ranbaxy fine chemicals - Haridwar (Veterinary & public test house

plant)

< Albert David - Kolkata ( LVP and SVP plant)

< Mission Pharmaceuticals - Indore ( OSD, Topical preparation and

Neutraceuticals)

< Beximco Infusions Limited - Dhaka, Bangladesh.

< Yiling Pharmaceuticals - Shijiazhuang, China

< Novozymes - China

< Qatar pharmaceuticals Limited - Qatar ( LVP plant)

< Central Research Institute - Kasauli (DPT Vaccine)

< Astrazeneca India Limited - Yelahanka (Tablet Production Facility)

Key Responsibilities Carried: Instrumental in preparation / review the

document for the validation & GMP compliance for USFDA, EU-GMP, WHO, UK

MHRA, & TGA certification, besides conducting validation workshops;

Prepare, Monitor and execute validation schedule completely .

M/S Himalaya Drug Company, Bangalore as Techno commercial officer -

Production Sep' 01 - Jun' 05

Since 1930 the company is engaged in manufacturing and marketing of

Pharmaceutical, Personal care and animal health products in various dosage

forms (Tablets, Capsules, Liquid oral etc). The company is involved in

marketing their wide range of products in domestic and also exports the

same in customized form to nearly 64 countries.

. Production planning, scheduling product deliveries, inventory

management, necessary documentations related to QA/QC.

. Liased between various departments; assuring the ongoing quality and

compliance of the products, including the review, release and

stability monitoring of products

. Evaluating the adequacy of existing QA processes, systems and

procedures

. Suggesting and leading the implementation of new and improved

processes, systems and procedures

. Participating in compliance auditing of internal systems; keeping GMP

requirements; providing guidance, interpretation and opinions on

compliance and GMP issues that impact the products.

. Extensive hands on experience in manufacture of pharmaceutical

formulations namely tablet, capsule, topical preparation, liquid orals

and all type of cosmetic products.

Technical skills

MS Word, MS Excel, MS PowerPoint, MS Visio, MS Project, and Internet

Usage Skills

Key Highlights

. Attended "Certified ISO9001 Implementer and internal auditor" course

for implementing QMS in the current organization and effectively

conducted internal audits.

. I represent myself as a QMS Representative from the emerging market

and an active member of the global QMS network group, thereby directly

report to our Global head office in Denmark.

. Witnessed complete lifecycle of the pharmaceutical operations.

. Witnessed complete lifecycle of validation.

. Active Member of ISPE.

Education

Master in Pharmacy - Rajiv Gandhi University of Health Sciences, Sept.'

2000

Bachelor in Pharmacy - Bangalore University, Sept.' 1997

Diploma in Pharmacy - S.J.R.C., Bangalore; Drug Control department of

Karnataka, Aug' 1992

References Available On Request

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