Manager Quality

Prasad.D.Oak

F***, Samanvay Status*,Near Banco company

40mtr Padara road,Atladra,Vadodara

+919*********; **********@**********.***

***********@*****.***

Date of Birth: 29th August 1968

Marital Status: Married

Summary of Experience

Skilled and dedicated Manager offering above 24 years’ experience in Injectable Vaccines Technical Operations serving in Secondary manufacturing (aseptic formulation, filling, lyophilization), proven expertise in aseptic techniques used in operation, having excellent leadership background and exposure to regulatory audits/requirements, a good understanding of quality management systems and microbiological aspects in sterile manufacturing looking for the oppertunity.

Responsible for Filling LYO & sealing area as Head -Filling,LYO & Sealing & Last year looking after Washing & Inactivation additionally as a support.

Aspiring for a lucrative opportunity to work in Sterile Secondary production.

Eager to work in an organization that inspires, encourages and recognizes talent and carries an excellent work culture.

Profile highlights

Expert in SAP-ERP processes related to PP and MM modules

GMP Aseptic filling operations

Setup of filling lines

Regulatory compliance and submission needs

Effective presentation Skills

Expertise in critical deviations

Microbiological failure investigations

Risk assessment & PQIA

Aseptic process validation

Quality Management System (QMS)

Professional experience

Chiron Behring Vaccines Pvt. Ltd. (GSK group)

Aug 1992 to till Oct 2016

Vaccines Division; Manager Production

Key Achievements and Certifications:

Certified as FDA approved technical person for parenteral manufacturing

Attended SME at CHINA in year 2012 and presented ANK site

Awarded with Novartis Star Award in year 2008 for exceeding the production targets and contamination prevention in filling operations

Awarded with certificate in year 2007 for consecutive 03 successful media fills with ZERO Contamination

Key Responsibilities Handled:

Leading team from aseptic formulation, filling, lyophilization to crimping of rabies antigen, effective production planning and control

Handling complaints, deviations and changes in Sentry Quality Management system

Successful and timely delivery of KPIs

Effective team management and work planning oriented to optimum results

Annual PMP review of associates

Conducted series of successful media simulations & developed processes to hone quality/poka-yoke in sterile filling

Built ‘All time audit ready’ department by orchestrating QMS, quality trending, risk assessment, APR, being >95% on RFT

Adherence to HSE guidelines, demonstrated best departmental performance with continuous ‘0’ lost time.

Involvements in key Project:

Aseptic roadmap in year 2012 where practices and facility was reviewed for best practices and to assign robust CAPA.

Quality orientation in year 2011 for 01 year for support and streamline of Compliance actions (QMS – DR, CR, CAPA, self-inspection, regulatory commitments, supplier qualification, Site wide synchronization of gowning procedure, plant layouts).

Ramped up efficiency to 75% of filling capacity in year 2010 with structured OE. (Production increased from 04 batches / week to 07 batches / week).

Installation and qualification of Petals vial washer & Filler, WHS, DHS and area renovation and qualification for commercial use in year 2009.

Reduction of Lyo cycle from 48 hr to 32 hr in year 2005.

Installation and qualification of Klenzaids Vial Washer & filler, WHS, DHS, Freeze dryer and qualification of filling area for commercial use in year 2004.

Machines Handled:

Vial Washing Machine (Make: Pharmalab, Klenzaids and Petals),

Mar’s tunnel which is integrated with, Klenzaids washing & filling line)

Vial filling Machine (Make: Klenzaids, Petal) & Vial cap sealing Machine (Make: Klenzaids)

Freeze Dryers (Make: Martin Christ, Germany) & Hoff (Make:Germany) of different capacities

Ampoule washing Machine and Ampoule Filling Machine (Make: Cadmach),

WHS (Machine Fabric & Pharmalab) and DHS (Saphire, Pharmalab and Machin Fabrik),

Palltronic & Sartopor FIT instrument. (Make: Pall & Sartorious)

Audits Faced: WHO-Geneva, Mexican, Russian Health Authority, South-Africa MCC, PAHO, Iran, China SFDA, CDSCO, GQO (Novartis divisional)

Validations Handled:

Process simulations (Media fills), Personnel gowning

Equipment validations (WHS, Tunnel & DHS, LAFs)

Education

B.Sc. Chemistry with 59% 1990

P.J. Science Collage, Bardoli

Professional Associations/Interests/Extracurricular Activities

Undertaking and imparting training on SAP/GMP/SOPs/Protocols/Media simulation

High visibility and routine interactions with Global TechOps, Quality

Reading, music and playing chess

Languages Known –English, Hindi, Marathi, Gujarati

Current CTC

Negotiable;

References – professional

Mr. Vivek Kulkarni, Freelance Consultant (Cell No: +919*********)

Mr. Nandkumar Gawde, Head – Secondary Production (Cell No: +917*********)

Mr. M. Y. Deshpande, GM–Production, Venky’s, Pune (Cell No: +919*********)

I hereby declare that the information provided above is true to the best of my knowledge.

Sincerely,

Prasad Oak.

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