QA, QC, Microbiology, Injectables, Quality, Capa, Qms, Investigations
Resume:
SATISH DARA
Mobile: +91-950*******, +91-779*******
E-mail: *************@*****.*** LinkedIn: https://in.linkedin.com/in/satish-dara-86ba8821
Accomplished QA professional with a Masters in Microbiology having 8.9 years of experience in Quality Assurance and QC-Microbiology in sterile injectable/parenteral manufacturing organization. Seeking middle level assignment in Quality Assurance with an organization of high repute in Pharmaceutical sector.
Profile Summary
Proven track record in managing day-to-day operations specifically with respect to team management, optimization of methods, procedures and systems.
Skilled in routine and non-routine validations.
Demonstrated expertise in handling analytical work, documentation as per regulatory compliance standards.
Strong team member with a great commitment in driving the team towards meeting the organizational objectives
Possess strong research, analytical, troubleshooting and interpersonal communication skills.
Participated and faced regulatory audits like USFDA, MHRA, ANVISA, WHO and audits of local FDA.
Organizational Experience
Designation
From
To
Organization
Assistant Manager
Jan-2018
Till date
Cipla
Laboratory Supervisor
July 2017
Dec-2017
Navya Biologicals Pvt.Ltd
Senior Officer
Nov-2015
June 2017
Johnson & Johnson Pvt. Ltd.
Senior Executive
May-2013
Aug-2015
Hospira Healthcare India Pvt. Ltd. (a Pfizer company)
Executive
Sep-2012
Apr-2013
Sequent Penems Pvt. Ltd. (subsidiary of Strides Arcolab)
Executive
Mar-2012
Sep-2012
Zenotech Laboratories Pvt. Ltd.
Executive
Jul-2009
Feb-2012
Aurobindo Pharma (Unit-IV)
Present Job Responsibilities (QA-Compliance & Investigations):
Handling of Investigations, Deviations, Batch failures, Incidents, OOS and OOT- Review, Evaluation, Follow up, Closing and Implementation.
Handling of CAPA – Review; Follow up, Closing and Implementation.
Reviewing data in context to Data Integrity and ALCOA+ principle.
Review and Evaluation of Change control documents.
Review of Equipment’s qualification, calibration and validation data.
Review of Validation protocols & reports.
Review of Quality Department documents as per the procedures and ensuring compliance.
To coordinate with cross functional department for closing of QMS related documents.
Review of SOP’s, STP’s and Raw material specifications.
Conducting internal audits to assess compliance with regulations, guidelines and operating procedures.
Conducting training sessions on cGMP to increase the awareness on Quality, GxP and Data integrity aspects across the respective functions.
Compliance to organization integrity and safety principles at all stages of operations.
Participate in external (Regulatory and Non-regulatory) audits.
Job Responsibilities handled in Microbiology Laboratory
Managed all microbiology lab operations for analytical and documentary compliance.
Managing and supervision of microbiological tests, designing protocols as per regulatory requirements.
Detecting and analyzing failures of microbiological tests, investigation and implementing CAPA for the same.
Managed the scheduling for environmental monitoring of manufacturing site.
Training and developing the laboratory personnel for continuous improvement of laboratory efficiency and productivity.
Managed lab equipment validation, calibration and maintenance activities.
Microbiology tests executed and supervised:
-Water sampling and microbiological analysis of water samples (Process water, Purified water and WFI).
-Environmental monitoring of Clean rooms.
-Media preparation, Growth promotion test and Media suitability tests.
-Sub culturing, preservation, maintenance and purity check of reference cultures.
-Isolation and identification of microorganisms using Vitek 2 Compact identification system.
-Sterility testing of in process samples and finished products using open and closed system.
-Participated in process simulation studies - Media Fill Trials (Sterile formulations).
-Population determination of Biological Indicators.
-Container Closure Integrity Testing – Microbiological method.
-Bacterial Endotoxin Test and Microbial Limit Test.
Microbiology validations executed and supervised:
-Sterility Test Method Validation.
-Water System Validation.
-Validation of Disinfectant Efficacy.
-Shelf life study of sterile media.
-HVAC Validation.
-Equipment validations (Incubators, LAF’S, BSC, Autoclave and other lab equipment’s).
-Microbiology miscellaneous validation studies.
Key Result Areas:
Successfully handled set-up of Microbiology Lab in two Green field projects
Contributed notably in project stage and involved in initial lab set-up and regulatory system implementation.
Played a pivotal role in development and implementation of microbiological tests with active participation.
Handled preparation of in-house SOPs, qualification of equipment, generation of reports, reviewing of documents.
Faced internal / external audits with respect to system compliance, documentation and regulatory requirements.
Competencies
Leadership:
-Communicating clearly and effectively.
-Adapting to individuals and situations when interacting with people.
-Receptive with an opened mind.
Document Management:
-Analyzing data as per ALCOA+ principle.
Problem Solving:
-Adopting a precise approach to problem solving within a regulatory context.
-Making realistic and appropriate decisions.
Quality Assurance:
-Ensuring product integrity and compliance based on standards and regulation.
-Monitoring compliance with cGMP, regulatory requirements and company standards.
Education
2009: Master of Science (M.Sc.) in Microbiology from Sri Venkateswara University, Tirupati, Andhra Pradesh
2007: Bachelor of Science (B.Sc.) in Microbiology from Osmania University, Hyderabad, Andhra Pradesh
IT Skills
Well versed with MS Office and internet applications.
Software - Trackwise
Achievements
Awarded as “Best Learner” in Leadership skill development program organized by J&J.
Certified Microbiologist by Johnson & Johnson Inc. Sterility Assurance, USA.
Awarded significant contributor to microbiology department during the year 2011-12.
Personal Details
Languages Known : English, Hindi & Telugu
Permanent Address: H.No.166, Saraswati Nagar Colony, Lothukunta, Trimulgherry, Sec-bad: 500015, Telangana,
Marital status : Married
Date of birth : 31st March 1986
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