QA/QC Manager, FDA - QP in Chemical,Instrumental, Microbiology,Sterili
Resume:
Technical strengths in PLANT/QA/QC/PRODN/PDD OF
STERILE SVP including Eye/Ear/Nasal Drops & LVP
NON-STERILE Tablets/Capsules/Syrups/Dry Syrups Creams/Ointments/Lotions
JOB SKILLS & PERSONAL STRENGTH(Hand-on Experience)
Worked on many formulations with cGMP facilities manufacturing Sterile as well as non-sterile products, having USFDA, MHRA, MCC, TGA, WHO accreditation. Well exposed to USP water system and HVAC with BMS.
Experience in Manufacturing of Tablets(Coated/Uncoated),ORS,Liquid Orals,Hard geletin capsules,external creams,ointments and lotions and sterile SVP & LVP, For Injectables Worked on BFS(Romolac) & Isolator Systems with QRM & PAT
Complete set up Production control, Utility control, Quality Control & Quality Assurance area with Quality Management Systems.
Pharma-Qualified Person (QP) from FDA
Chemical & Instrumental
Microbiology & Sterility
Pyrogen(animal testing) and Toxicity(animal testing) of Paranteral prodcts.
R.M./Packaging Material sourcing,Training programs to train people technicaly in machinery, production areas and team building.
Worked on
Quality System
Production System
Material System
Packaging System
Facility & Equipment System
o Equipments and Instruments Qualifications (URS, DQ, FAT, IQ, OQ & PQ)
o Cleaning validation – Sound hands of experience with respect to compliance of various International regulatory requirements.
o Stability studies as per ICH guidelines.( Samples management, Scheduling, analysis, Documentation & data generation )
o System deviation - investigation and control based on Statistical analysis.
o Writing, issue and control of SOP’s, Specifications & Protocols.
o Training, evaluation and Certification.
o Management of Standards – Reference, Working & Primary Standards.
o Investigation & Compliance of market complaints.
o FDA Liasoning and all related activities.
o Work planning, allocation and manpower management.
o Self-inspection / internal audits - Auditee / Auditor.
o Approvals and Monitoring of Change Controls, Process & Plan Deviations.
KEY COMPETENCE AREA
• Analytical Method Development & Validations.
• Expertise in latest analytical techniques. (HPLC, GC, TOC, Spectrophotometers etc.).
• Auditing & Training - GMP / GLP / Total Quality Management.
• Validations – HVAC, Water Systems, Manufacturing facilities & Processes.
• Cleaning Validation with respect to product specific acceptance criteria.
• Documentation and compliance of various regulatory & customer requirements.
• Administration Management (Handled workforce of more than 200 Headcounts).
PROFESSIONAL ACHIEVEMENTS
• Technically Qualified for Chemical & Instrumentation analysis from FDA Maharashtra.
• Technically Qualified for Microbiology & Sterility testing from FDA Maharashtra.
• Technically Qualified for Pyrogen & Toxicity from FDA Maharashtra.
• Actively Participated as well as lead the team for Successful Accreditation of WHO-GMP Compliance Regulatory Approvals.
Present Status: Since Last 1 year, Working as a Head-QA (Africa Operations) with M/S Strides Arcolab Limited a cGMP compliant MNC having plants world wide in Europe, America, Africa and India.
Nature of Job Responsibilities :
o To assure compliance of Quality Management System.
o Internal &External Quality audits.
o Vendor control.
o SOP control
o Document control
o Preparation of Site Master File and Quality Manual.
o Qualification and Validation control.
o Change Management.
o CAPA Management.
o Deviation Management.
o Quality Risk Management.
o APQR
o Training
o Validation of Facility,Services,Equipments & Instruments.
o Validation of Analytical Methods.
o Validation of production processes.
o Plant control including machinaries and utilities.
o Production control including Quality & Quantity.
o Staff handling and training.
o Preparation & Planning of external & internal audits.
o Preparation of different validation protocols.
o To look after Analytical development, Analytical troubleshooting & PM / RM vendor development & testing work. Including Cost Reduction.
o To facilitate & follow up of internal / external quality audits & training plans and to conduct various technical training programmes.
o RELEASE / REJECTION decision for all materials / products.
o Responsible for all Technical Issues related to Product Development & Quality.
Reporting – CEO.
CARRIER PROFILE
COMPANY BUSINESS Position Handled
M/s Bioplus Life Science
Bengaluru, India.
(2011 to………)
Middle East Pharma & Food Supplement products Sr. Manager-Technical affairs
(International Operations)
Responsibilities-
Technical support related to Quality system, Production, F & D, QA, QC, TT, Regulatory, Audits, Training, Risk Management, Documentation
M/s Strides Arcolab Limited
Bangalore, India.
Since last 1 year
(2009 to 2011) Drug Formulations
Sterile/Non-Sterile Head-QA
(Africa Operations)
Responsibilities-
Quality system, Regulatory, Change management, CAPA, Deviation management, OOS, OOT, Market complaint, Quality Risk Management, Training, Document control, APQR, Validation & Qualification. Quality control- Analyst Qualifications, Analytical method development and validations, Vendor control, Internal & External audits.
Specifications, STP & SGP,
MFR/MPR/BMR/BPR control.
PharmaSphere Ltd.
Alger,Algeria.
For 1 year.
(2008-2009) Drug Formulation
(Non-Sterile) Site Manager
Responsibilities-
URS, Facility, Utility, Equipments Qualification & Validations. FAT & SAT Designing of protocols, Design control, Quality System, Process control, Material control, Packaging control, Change control.
Validation & Calibration.
Unichem Industries Ltd
Accra,Ghana.
For 1&1/2 Years
(2006-2008) Drug Formulation
(Non-Sterile) General Manager
Responsibilities-
Facility, Utility, Equipment set up, Documentation, Start the commercial production, Set formulations with initial 3 batches process validations, product costing, Staff recruitment, Training.
Zenufa Laboratories Ltd
Dar-Es-Salaam,Tanzania.
Kinshasa,D.R.Congo
For 4 Years
(2002-2006) Drug Formulation
(Non-Sterile) Technical Manager
Responsibilities-
Design control of
Facility design, HVAC, Water system design, product design, URS design, FAT, SAT, Qualifications, Validations, Documentation-protocols control.
Production process control.
Material control, Packaging developments.
Elys (Kenya) Limited.
Nairobi – Kenya.
For 4 Years.
(1998-2002) Drug Formulations (Sterile / Non-Sterile) Head - QA / QC & Product Development
Responsibilities-
Development in Manufacturing equipments, HVAC, Water system, Laboratory set up including HPLC analysis and method development and validation, microbiology, Formulation development and stability studies. Process & Analytical methods training.
Ivee Aqua Ltd.
Nairobi-Kenya
For 2 year
(1996 to 1998) Drug Formulations
(Sterile LVP&SVP) Technical Head
Responsibilities-
To set Sterile Eye drop formulations on BFS machine, Manufacturing, Utility & Laboratory equipment set up, provide training in sterility testing & Manufacturing, Formulation developments and Stability studies, Sourcing of equipments, Raw Materials, Packaging developments etc.
Ciron Drugs & Pharma Limited. Tarapur, Dist- Thane (India).
For 6 Years.
(1989-1995) Drug Formulations (Sterile / Non-Sterile) QA / QC Incharge
Responsibilities-
Approval/Rejection of R.M/F.P./P.M. and Follow up of Quality System, Approving SOPs and Protocols, Control on Validations, Qualifications
Bini Laboratories Pvt. Limited.
Nashik (India).
For 3 Years.
(1986-1989) Drug Formulations
(Non-Sterile) QC Trainee to QC Incharge
Responsibilities-
As a Q.C.trainee in R.M/F.P/P.M sampling/analysis
Writing Q.C.-SOPs, Microbiology analysis.
PERSONAL DETAILS
Name (Full ) : Prabhukeluskar Rajendra Ramakant
Address (Permanent) : D-204, Neminath Nagar, Achole Road,
Nalasopara (East)
Dist- Thane, Maharashtra – 401 209. (India).
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Contact No. (Resi.) : 096********
Passport No. : H0293730 Valid up to 24/08/2018
(Income tax) PAN No. : APBPP8796G
Date of Birth : 19th November'1965.
Marital Status : Married (Family : Spouce & 2 Daughters)
Languages known : Marathi, Hindi, English, Kiswahili (African Language)
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Qualification : B.Sc, M.Sc-I from Mumbai University and Pharma Tech, FDA-QP
Computer Knowledge :
Sound working hand on computers (Windows based programme)
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