SAMI SHAIK
Visakhapatnam
Summary
- Experience in the development, implementation,and lifecycle management of computerized systems in regulated environments.
- Good understanding of global regulations and health authorities expectations governing CSV, 21CFR Part11, GAMP5, Annex11, Data Integrity.
- Reviewing documentation evidence covering identification of instruments, frequency of re-calibration, calibration status
- Working with Operations Department and Technical Services for effective operational control, organizing test runs of new feed, specific product specification requirements
- Interfacing with customers, surveyors for complaints and organizing retesting after product transfers and clarification of test results, test methods used and testing requirements
- Organizing and managing activities of the Incoming Feed, In-process and Finished Products Section to the specified requirements in accordance with the quality plan and documented procedures
- Training employees as Chemists, Analysts, Technicians, for process engineer’s familiarization in the laboratory
- Identifying, calibrating and adjusting all inspection, measuring and testing equipment and devices that can affect product quality at prescribed intervals or prior to use
- Providing analytical support to R&D and pilot scale laboratories for analytics
- Monitoring the Quality Control Department activities towards ensuring the timely service to all internal customers
- Generating monthly reports which include No. of Incidents & OOS, HPLC&GC Utilization Time, Budget Details pertaining to the lab
- Spearheading day-to-day planning for analysis of raw materials, in- process samples, finished products, and stability samples
- Reviewing Analytical Reports & improving quality standards in the organization by implementation of new processes
- Preparing IQ, OQ and PQ protocols for Q.C related instruments & non-conformities, Out Of Specification (OOS) reports
- Introducing and enforcing quality systems / procedures to ensure strict adherence to specified quality norms
- Implementing preventive, predictive & corrective maintenance practices to maximize operational availability of machines
- Providing key scientific and technical support for issues related with Process/Analytical/ Packaging at the facility
- Led execution of Quality activities like transfers of analytical methods, validation and their regulatory submissions, evaluation of pharmacopoeia method against in-house developed methods & routine release analysis in Quality Control Laboratory
- Hands on experience in handling, maintenance and troubleshooting & calibration of lab equipments like HPLC,GC& GC with HS, ( Waters, Agilent, Shimadzu, Dionex)UV-VIS, FTIR, KF Autotitrator andLC-MS/MS
- Overseeing new laboratory setup and equipment setup.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Assistant General Manager- CSV
Vasan Software Technologies
02.2024 - Current
Head of the Department-Quality Control
Spar Pharma LLP (Unit of Vijayasri Organics Pvt. Ltd)
10.2022 - 08.2023
Head of the Department- Quality Control
Vijayasri Organics Pvt. Ltd.
05.2019 - 10.2022
Dy. Manager - Analytical Research & Development
Shilpa Medicare Ltd.
08.2012 - 04.2019
Sr. Executive - QC Department
Dr. Reddy’s Laboratories Ltd.
12.2011 - 08.2012
Officer - QC
Neuland Laboratories Ltd.
03.2009 - 12.2011
Chemist - QC
Jupiter Biosciences Ltd.
02.2005 - 03.2009
Education
Masters of Science in Bio-Chemistry - Biochemistry
University College, Acharya Nagarjuna University
Andhra Pradesh, India2004
Bachelors of Science in Botany, Zoology&Chemistry - Lifescience
PBN College, Nagarjuna University
2001
Skills
- Quality Control & Quality Assurance
- Computer System Validations
- Internal, External & Vendor Audits
- Analytical Method Development, Validation & Transfer
- Regulatory Adherence & Compliance Management
- Stability Studies
- Total Quality Management
- Project Planning & Execution
- Deviation & Change Control
- Training & Team Development
Certification
- Certification in Computer System Validation
- Certificate course in Computer Basics (MS Word, MS Excel)
Personal Information
- Date of Birth: 03/05/1980
- Known Languages: English, Hindi and Telugu
Timeline
Assistant General Manager- CSV
Vasan Software Technologies
02.2024 - Current
Head of the Department-Quality Control
Spar Pharma LLP (Unit of Vijayasri Organics Pvt. Ltd)
10.2022 - 08.2023
Head of the Department- Quality Control
Vijayasri Organics Pvt. Ltd.
05.2019 - 10.2022
Dy. Manager - Analytical Research & Development
Shilpa Medicare Ltd.
08.2012 - 04.2019
Sr. Executive - QC Department
Dr. Reddy’s Laboratories Ltd.
12.2011 - 08.2012
Officer - QC
Neuland Laboratories Ltd.
03.2009 - 12.2011
Chemist - QC
Jupiter Biosciences Ltd.
02.2005 - 03.2009
Masters of Science in Bio-Chemistry - Biochemistry
University College, Acharya Nagarjuna University
Bachelors of Science in Botany, Zoology&Chemistry - Lifescience
PBN College, Nagarjuna University
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