Johnson Joseph is an experienced quality professional seeking a management position. He has over 10 years of experience in quality analysis and ensuring compliance with regulatory standards like US-FDA, WHO, and local authorities. He is skilled in quality operations like audits, validations, environmental monitoring, and handling regulatory approvals and licenses. His expertise includes microbiological testing, method development, process simulation, and instrument qualification.

1. Johnson Joseph
Flat No7, 2nd
Floor, Sai Sreeji Apartment, Srinagar, Sector 7, Wagle Estate, Thane West,
Mumbai.
E-mail: johnzy.duke@gmail.com. Mobile:
8888500074/9987489563
Objective
Experienced candidate seeking to obtain a Management position in which I can contribute
my quality analysis, technical expertise, documentation experience in a dynamic work
environment.
Profile Summary
• Ten Years of experience in result-oriented professional with excellence in
implementing quality mechanisms to deliver desired output
• Good communication and interpersonal skills.
• Acquired comprehensive exposure in planning and organizing day-to-day activities
and executing tasks on a timely basis.
• Resourceful in reviewing the operational practices, identify the areas of
obstruction/ quality failures and work on system for qualitative improvement;
maintaining revenue and budget
• An energetic, self-motivated team player with hands on experience in requirements
gathering, examination, evaluation and customization.
Education Summary
Master of Science in Microbiology: (2004 - 2006),
Dayananda Sagar College, Bangalore University.
Bachelor’s Degree in Microbiology: (2001 - 2004),
St. Joseph’s College of Arts and Science, Bangalore University.
Diploma in Cell and Molecular Biology: (2005),
St. Joseph’s College of Arts and Science, Bangalore University.
Masters in Business Administration in Production & Quality management (2011)
Madurai Kamaraj University.

2. Selected Accomplishments
• Successfully trained entire QC staff personnel in cGMP and Laboratory operations.
• Successfully Faced US-FDA, WHO & local FDA audits.
• Have successfully faced various Global Quality audits conducted by Perrigo.
• Have Validated Two different Water System over a period of Two Years.
• Actively involved in Clean Room Qualification of Formulation Plants and API Plant.
Work Experience
Approved by Food and Drug Administration Govt. Of Maharashtra as Competent
Technical Person in the field of Microbiology.
Assistant Manager Quality: Jun 2011 – Present, Perrigo India, Mumbai.
-------------------------------------------------------------------------------------------------------------------------
------
Senior Executive Quality Control: July 2008 – Jun 2011, Reliance Life Sciences Private
Limited, Mumbai, India.
-------------------------------------------------------------------------------------------------------------------------
------
Executive Quality Control: July 2006 - July 2008, Pharmasolve Private Limited (Cipla),
Mumbai.
Responsibilities Handled:
• Independent planning and allocation of work to subordinates for execution of all
daily activities in the microbiology lab.
• Management of controlled documents into a quality system designed to prevent
and correct quality problems and which includes the review and approval of
Standard Operating Procedures (SOPs).
• Checking/ Review of microbiological raw data, stability reports and technical
documents.
• Maintenance and Identification of pure cultures and environment isolates to their
Species level using API Kits.
• Microbial Limit Test (MLT) of finished products, raw materials and intermediates.

3. • Sterility testing and method validation for raw materials and finished products by
open and closed system.
• Routine Microbial analysis of Potable, Purified, Steam condensate and Water for
Injections.
• Bacterial Endotoxin Test (LAL) for WFI, intermediates, raw materials and finished
products by gel clot method and Photometric method (PTS) and have performed
product validations.
• Environmental monitoring of classified cleanrooms by settling plate, air sampling,
contact plate, swab and by finger dab and Non viable count monitoring.
• Evaluation and monitoring of disinfectants.
• Media Fill (Process Simulation Activity) for Small Volume and Large Volume
Parenteral.
• Antibiotic assays using microbial cultures and Probiotic assays.
• Preservative efficacy testing for pharmaceutical products.
• Handled instruments like TOC analyzer, HPLC, Atomic Absorption/Emission
Spectrophotometer, UV Spectrophotometer.
• Preparation of stability protocols, stability reports and trending.
• Microbiological Method development and Tech transfer for new products.
• Estimation and method validation of protein by ELISA technique.
• Prepare Qualification Protocols and Reports for systems like Water, HVAC and
Execute the activity on timely basis.
• Carrying out routine validations & actions to be taken if results are not within
specified limits; planning manpower for smooth execution, reaching to quality,
quantity, time & cost parameters
• Designing, procurement of Instruments and commissioning of the new
Microbiology Laboratory. Preparation of URS and technical evaluations of vendors.
Negotiation with the vendors for procurement of quality instruments.
• Preparation and execution of IQ/OQ/PQ for instruments like Autoclave, DHS, LAF,
Biosafety cabinets, Incubators, Refrigerators and Stability Chambers.
• To lead cross-functional teams (Microbiology, QA, manufacturing, engineering,
validation etc) as needed for investigations and environmental excursions. Active
participation in root cause analysis and proposal for preventive maintenance.
Maintenance of plant hygiene practices.
• Active networking with other microbiologists across overseas site to provide
technical expertise and to harmonize corporate guidelines.
• Handling of SAP and LMS for quality control related functions.
• Perform Internal Audits at site (Manufacturing facilities, Quality Control laboratory)
etc.
• Actively involved in Review of COA and SPECIFICATION.

4. • Monitoring progress on quality related corrective and preventive actions to assure
timely compliance.
• Working with other site departments to identify root causes to identified problems
and opportunities for quality system improvements.
• Product complaint handling and ensuring that returned products are properly
managed and controlled.
• Expertise in handling Quality Operations including OOS, OOT, Change control &
Deviations.
• Involved in applying and approval of Manufacturing License, Test license, NOC for
new drugs and Import license from FDA.
• Involved in application and getting written confirmation approval from CDSCO and
DCGI for product export to European markets.
• Review/Verification of Finished goods consignment for customers.
• Performing vendor audits for approval of key raw materials and intermediate.
• Preparation of Annual product review report for water system and products.
Personal Traits
Date of Birth : 19th
October 1982
Marital Status : Single
Nationality : Indian
Languages Known: English , Hindi, Kannada , Marathi ,Malayalam and Tamil.
Contact Me
Alternate E-mail: joseph_john83@yahoo.com
Postal Address: Flat No7, 2nd Floor, Sai Sreeji apartments, Sector 7, Wagle Estate , Thane
West, Mumbai.

5. Johnson Joseph

6. Johnson Joseph