SANTOSH SHIVAJI INGAVALE

Contact: +91-771******* / 91-772*******

E-Mail: - aceofu@r.postjobfree.com

PRODUCTION OPERATIONS PROFESSIONAL

Operations Management ~ Factory Administration ~ Quality Assurance

A dedicated Pharmacist, proficient in running successful method-oriented

production operations & taking initiatives for business excellence through

process improvement

Seeking challenging assignments in Production Operations / Operations

Management with an organization of repute in Pharmaceutical / Medical /

Healthcare sector, preferably in Mumbai /India.

PROFILE SUMMARY

. A dynamic professional with nearly 15 years of experience in:

Production Operations Factory Administration Quality

Assurance

Operations Management People Management

Inspection & Troubleshooting

. Proficient in managing complete production operations as per WHO-GMP

norms (Tablets, Capsules, DPS, Oral liquids, Creams & Ointments,

Injections & Penicillin Formulations) involving resource planning,

materials planning & co-ordination with internal departments

. Expertise in ensuring compliance of various quality measures by

maintenance of appropriate requisite documentation/ records

. Adroit in executing cost saving techniques / measures & modifications to

achieve substantial reduction in O&M expenditures and work within the

budget

. Deft at implementing maintenance schedules & carrying out periodic checks

to ensure performance of various equipment and maintaining requisite

documents for the same

. A result - oriented individual with leadership, excellent planning &

execution, decision making skills

CORE COMPETENCIES

. Formulating & executing production and manpower schedules / plans for

smooth execution of projects at within time & cost parameters

. Coordinating with various departments including material department for

ensuring accomplishment of daily & monthly production targets; ensuring

cost reduction by implementing new techniques and working on productivity

improvement

. Implementing quality tools to ensure process capability per specification

requirements, monitoring control plan preparing and implementing

improvement & corrective action plan

. Developing quality plans & ensuring quality assurance for equipment in

manufacturing by inspection control in various stages & managing process

control as per standards

. Spearheading plant activities involving working out various requirements

& monitoring overall operations for ensuring timely completion of certain

activities

. Monitoring the activities at sites, undertaking review of schedule,

ensuring cost control within budget, planning for cash flow requirements,

etc.

. Effectuating predictive, preventive & breakdown maintenance schedules of

plant assets; conducting periodic checks to ensure performance of various

equipment

ORGANIZATIONAL EXPERIENCE

Since Jan'06 Laboratory & Allied Ltd., Nairobi, Kenya

Growth Path:

Jan'06 - Feb'07 Production Coordinator (Production Manager)

Feb'07 - Aug'10 Deputy QA Manager

Aug'10 - Oct'12 QA Manager

Nov'12 - Apr'14 Manager - Operations/Production

Role:

As Manager - Operations / Production

. Responsible for managing:

o New factory set up, qualification, installation and operations of new

facility

o Day-to-day, overall factory functions and activities

. Interacting with Production Coordinators & Managers for day-to-day

activities & verification of daily report

. Ensure timely follow-up with Purchase, QC & Raw Materials Departments

. Handling quality production as per cGMP norms & GMP procedures

. Representing company at national and international levels

. Recommending or suggesting process reduction cycle to reduce cost of R&D

. Approving design qualification for any new required machinery/ equipment

. Conducting GMP inspections, training, etc.

. Heading all the factory related activities

. Functioning as Member of Market Complaint, Recall & Product Development

Team

Highlights:

. Attended various WHO workshops across the globe on quality documentation

as per CGMP norms

. Served as member of PICS Project in 2006-07

. Represented the company & upgraded the setting up of the plant

. Successfully monitored the preparation of design and implementation &

validation of Water Treatment Plant & Loop System

. Functioned as Team Leader for preparation of conceptual design, set-up,

actual commissioning & performance of new WHO-GMP Facility

As QA Manager

. Served as Leader/member in external & internal inspections/audits

. Responsible for GMP:

o Documentation & implementation

o Administration as per SOPs, master records & protocols

. Ensured VMP in place and confirm the PV/CV/AV

. Obtained approval of SMF, QM and VMP

. Managed change control, incident/deviation & documentation of deviation

as per procedure & CAPA implementation & management

. Imparted GMP training to staff and senior management

. Handled authorization of batch records, specifications, GMP documents,

self-inspection, incident/deviation, planned deviation, change control

and CAPA

. Released batch for sale in absence of company pharmacist (authorized

person)

. Oversaw federation activities & ensured representations at different

forum (such as WHO, UNIDO, regulatory)

. Ensured and organized suppliers audit and qualification of suppliers as

per procedure

. Served as Member of market complaint investigation committee and

implemented CAPA & interacted with Sales and Customers

. Functioned as Project Leader for preparation of conceptual design of new

WHO GMP Plant/Facility

As Assistant QA Manager

. Ensured VMP in place & confirmed the PV/CV/AV and followed revalidation

matrix

. Investigated incidents /deviations, identified root causes and ensured

action plan of CAPA

. Derived administrative additional responsibility of QC activities during

vacancy of QCM

. Updated BMR & developed design of new documents of APQR/SOPs/BMRs

. Conducted suppliers audit & qualification of suppliers as per procedure

. Served as Member of Market Complaint Investigation Committee and

responsible for implementation of CAPA

. Imparted PIC/S training project 2006-2008, (PPP-BEGECCA- Germany)

arranged by Kenyan Govt., Public Sector and German Govt. to upgrade local

manufacturers at PIC/S level

Highlights:

Manager Operations

Served as the Health and Safety Coordinator

Production Manager

. Served as Team Member in reducing the process cycle time

QA Manager

. Imparted on the job-training and managed system implementation in Shop

Floor

. Functioned as Team Leader for preparation of policies, registration, GMP,

training, audits & CAPA implementation

. Played a vital role in establishing the dissolution method / analytical

method at National Laboratory in coordination with National Laboratory as

part of harmonization & troubleshooting

. Successfully handled the development of CAPA during re-working & re-

processing to achieve FP-specification

. Acted as:

o Team Leader/ Member for external inspections from Regional, NGO's and

International Regulatory Authorities such as PIC/S, PPB,

TFDA,NDA,PMPB, WHO, MCC, CHMP, ICRC and MEDS

o Leader in TTI-Roche Project

. Actively participated in UNIDO Workshops for preparation of UNIDO report

Improvement of Kenyan Local Pharmaceutical Manufacturers

PREVIOUS EXPERIENCE

Jun'02 - Jan'06 Raptakos Breet & Co. Ltd., Thane as Production

Executive / HOD- Solid Dosage Forms

Oct'01 - Jun'02 M.J. Bio-Pharma, New Mumbai as Production

Officer (WHO-GMP, MCC)

May'01 - Sep'01 Pharmacy Chemist, Mumbai as Dispensing Pharmacist

Aug'99 - Apr'01 Meyer Organics Ltd., Thane as Production Officer-

Loan Licensee Coordinator

KNOWLEDGE PURVIEW

. Well versed with GMP & cGMP documentation and exposed to various cGMP

audits

. Preparation of SOPs, QM, SMF, Risk Analysis and GMP Training

presentation.

. APQR and Coordination of Validations (4Q's/PV/CV) Stability &

Compatibility Studies

. Handling of Incidents, Deviations and Change Controls

EDUCATION

. MBA-Operations from Amity University, NOIDA, INDIA.

. DBM- Correspondence from Prin. Welingkar Institute of Management,

Matunga, Dadar, Mumbai in 2000

. B.Pharma from SRTMU, Nanded, MS with 77.18 % (Distinction)in 1999

o Secured 3rd Rank

. D-Pharm-II from Govt. College of Pharmacy, Karad, MS with 72.75% in 1995

o Secured 1st Rank

ACADEMIC ACCOLADES

. Qualified OPENMAT Entrance Examination of IGNOU for MBA in 2003

. Recognized as Qualified Person and obtained FDA Approval in Tablets -

Maharashtra

TRAININGS ATTENDED

. WHO-Documentation Training in 1999 at Meyer Organics Ltd., Thane, India

. MCC/WHO Documentation Training in 2001 at MJ Pharma/ Shreya Healthcare

Ltd. Mumbai

. 'Kaizen' Training (Part) in 2005 at Raptakos Breet & Co. Ltd. Thane,

India

. Health & Safety training workshop in 2005 at Health & Safety Institute,

Mumbai

. PIC/S Training (Practical/Theory) series in 2006-2007 by PIC/S- BEGECCA,

Germany at Laboratory & Allied Ltd.

. Pharma-Q cGMP Documentation Training in 2008/09 at Laboratory & Allied

Ltd.

. ROCHE-TTI, France- cGMP Training at Johannesburg, South Africa in 2008

. WHO-cGMP Workshop in 2011 at Nairobi

. WHO-GIZ-EAC- cGMP 5 days' Workshop at ARUSHA, TZ in Oct-2012

. WHO-Prequalification Training Module- I/II/III held by GIZ/German Govt. &

FEAPM at Nairobi Kenya- in Jan/Feb/Mar-2013

. Participant in GMP-workshop by Insights systems at Thane on updates on

GMP by USFDA, MHRA, EU/PICS/WHO at Thane in may-2014.

IT SKILLS

. LINX and Pharma-Suite System

. MS Office (Word, Excel & PowerPoint)

. Internet Applications

PERSONAL DETAILS

Date of Birth: 23rd November 1976

Address: 702, Lawrence House, Disoza'wadi, Wagle Estate, Thane-

400604, MS

Language Known: English & Hindi

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