Ch P.
INTAS Pharma l Ex Sigachi industries l Ex Pidilite Industries l Ex Leadec-Asian paints l Ex Pioneer aluminum
- Role
- Assistant Manager-21cfr Projects-engineering-instrumentation at Intas Pharmaceuticals
- Location
- Visakhapatnam, AP, IN
- LinkedIn followers
- 500 followers
About Ch P.
Actively looking for job
Experience
Assistant Manager-21cfr Projects-engineering-instrumentation
Dec 2024 — Present · Ahmedabad, IN
Iam in 21 CFR projects in intas pharma ltd, my role typically involves ensuring the proper functioning, maintenance, and compliance of instrumentation systems and equipment used in regulated environments, such as pharmaceutical manufacturing or laboratories. This includes validation, calibration, maintenance, and troubleshooting of instrumentation systems, as well as ensuring compliance with regulations like 21 CFR Part 11 for electronic records and signatures.Key Responsibilities in 21 CFR Projects:Validation and Compliance:Ensuring that computerized systems, including those used for data acquisition, control, and recording, meet the requirements of 21 CFR Part 11, which outlines requirements for electronic records and signatures. This includes ensuring proper system validation, audit trails, and electronic signatures. Maintenance and Calibration:Performing routine maintenance, troubleshooting, and calibration of instrumentation systems and equipment. Preventive Maintenance: Developing and implementing preventive maintenance schedules to ensure the reliability and functionality of instrumentation systems. Breakdown Maintenance: Responding to and resolving breakdowns or failures of instrumentation systems. System Design and Installation: Participating in the design, installation, and commissioning of new instrumentation systems. Data Integrity: Ensuring the integrity of data generated by instrumentation systems, including data storage, retrieval, and analysis. Documentation: Maintaining accurate and complete records of all maintenance, calibration, and validation activities. Collaboration: Working with other engineering disciplines, operations, and quality assurance teams to ensure the successful implementation of projects. 21 CFR Projects: SCADA Systems, PLC Systems, Data Acquisition Systems, Environmental Monitoring Systems, Laboratory Equipment, Compliance with 21 CFR Part 11, Electronic Records, Electronic Signatures, Audit Trails.
Education
Chaintanya Institute of Engineering
Master of Technology (M.Tech.)
2015 — 2017
Gayathri juniour college, tuni
Intermediate, MPC
2004 — 2006
Z P High School, S.narsapuram
10 Th Class
2002 — 2004
Jawaharlal Nehru Technological University Kakinada (JNTUK)
Bachelor of Technology - BTech
2006 — 2010
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