Name: Mahesh Nadipineni

Phone No: + 91-9618699373

Email: maheshnadipineni123.csv@gmail.com

Career objective:
Having 3.9 years of experience in performing validation of system and to get elevated in the field
assigned to me by exploring my skills etc and work to the best of my ability for the benefit of the
organization. Willing to work at a responsible position as a system analyst in a renowned
organization.

Profile Summary:

 Comprehensive knowledge of the methods, techniques, and process of system validation

and verification
 Hands on experience in testing validation process of large and sub systems
 Ensure quality and compliance in accordance with established procedures and standards of
the Quality
 Generate base level document such as URS, FRS, DS, and SOPs in support of validation
activities.
 Generate and execute computer validation (IQ, OQ, and PQ) documentation (for systems
such as lab software, quality systems software and associated business system interfaces).
 documents to support the start-up, validation, operation and maintenance of site GMP
automation and enterprise
 Coordinates the timely execution of validation
 Develop and implement validation master plans for computer systems, facilities and
equipment validation.
 Perform gap analysis on current computer system to ensure compliance with Part 11 and
Annex 11.
 Facilitate the computer system validation Risk Assessment to identify governing
regulations and validation deliverables during the development of the computer
 Perform Periodic System Reviews ensuring that the systems maintain their validated
 Ensures documentation and practices to meet quality standards, applicable and company’s
policies and procedures
 Ability to communicate effectively with sound analytical skills

Skills
 CSV, GAMP 5, 21CFR Part 11, EU Anex11, CAPA, Change Control, GCP, GMP, GLP, GAMP,
GAMP 5, Project Management, SDLC.
Work Experience:
Computer system validation Analyst
Biological E Limited.
Hyderabad
November 2018 to Till Now

Roles and Responsibilities

 Hands on computer system validation on assigned projects

 Played major role in computer system validation and compliance activities.
 Responsible for creation, execution and coordination of the project’s deliverables
 Develop validation documents such as user requirements, functional specifications,
validation plans, test plans, traceability matrix, deviations and summary reports
 Computer System Validation advisory for the planned system upgrades
 Responsible for authoring GxP assessment, DI assessment, ERES assessment documents.
 Performed GAP analysis and authored respective Mitigation documents.
 Ensures documentation and practices to meet quality standards, applicable and company’s
policies and procedures
 Perform risk assessment in support of computer system validation
 Provide basic functional support for quality systems
 Responsible for Preparation, review and execution of Installation, Operational and
Performance Qualification protocols.
 Experience in creation and review of Standard Operating Procedures (SOP’s)
 Providing Quality and Compliance expertise to ensure System compliance with
requirements.
 Involved in analysis and collection of requirements for validation activity of computer
system by mutual discussions with the stake holders.
 Involved in Internal Quality audits
 Support regulatory and customer audits
 Responsible for reviewing CAPA’s and Change Control forms
 Completing 21 CFR Part 11 compliance assessments of laboratory including remediation
and validation of deficient systems
 Training people on 21 CFR part 11 regulations
 Training the team members on validation principles, processes and quality Reviewing,
Developing and maintaining GAMP lifecycle documentation.
 Responsible for reviewing end to end validation deliverables of GxP impacting computer
systems.
 Responsible for maintaining computer system validation documentation and archiving
ensuring effective document retrieval when required
 Coordinate and manage validation and qualification testing documentation review,
approval signoff, execution, and post-execution review
 Responsible for authoring GXP assessment, System categorization, Validation plan and
Summary reports.
 Preparation, review of Installation, Operational and Performance Qualification protocols.
  Qualification of analytical instrument software’s with compliance to the 21 CFR Part 11.
 Support regulatory and customer audits

Education:

Qualification Title Intuition/Board Year of Percentage

Passing of Marks

MCA(Master of computer 2017 80

JNTU University- Kakinada
applications)

BSC-MSCS(Degree) Sri Prathibha Degree college, Kandukur 2013 75

Higher Secondary (12th 2009 75

Sri Viveka Junior College, Kandukur
Standard)
Secondary Schooling (10th
Vikas high School – Kandukur 2007 80
Standard)

Additional Information:
 Operating System: Windows XP/7/8, Access, Excel, Word, Power Point, Outlook, Scada,
PLC
 Validation/ Testing: Software Testing Diploma (Manual/ Automation) / Test case writing,
 Pharma Tracking Software: Track wise System, LMS
 Automation Testing Tool: Hands of knowledge HP ALM

DECLARATION:

I certify that the mentioned above are true to the best of my knowledge and belief.

Date:

Place: Mahesh N