Walkin on 13th Sep
Company Dr. Reddys Laboratories Ltd.Qualification Any Graduate
Experience 3 to 7 yrs
No of Openings 10
Work Location Hyderabad and Visakhapatnam
Job Description
Dr. Reddys Laboratories Walkin Drive for Computer System Validation for Hyderabad and Visakhapatnam LocationsRole: Assistant Manager - Computerized Systems Validation (CSV)
Number of positions available: 10
Location: Formulation Technical Operations, Hyderabad (Bachupally) and Visakhapatnam (Duvvada & Pydibhimavaram)
Job Description:
1. CSV Lead for computerized systems in regulated environment.
2. Define risk based strategies for the validation of computerized systems, which include but not limited to validation methodologies and testing activities, and author/review end-to-end Computerized Systems Validation documentation in accordance with Computerized Systems Validation Master Plan.
3. Authoring/reviewing SOPs relevant to Computerized Systems Validation.
4. Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
5. Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
6. Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel.
7. Ensure the compliance of computerized systems to regulatory requirements, including but not limited to 21 CFR Parts 210, 211, Part 11 and Eudralex Vol.4 - Annex 11.
8. Review change controls and perform periodic reviews
9. Establish and implement corrective actions and preventive actions where appropriate, and process improvement initiatives.
10. Face regulatory, customer, IT Quality System related inspections for all computerized systems across the Formulation units
Technical Requirements:
Expert knowledge on the following
a. 21 CFR Part 11 / Eudralex Vol.4 - Annex 11 compliance
b. Quality Management and Information Security standards
Proven expertise in the validation of at least two of the following systems
Process analytical technology (PAT)
Manufacturing Execution Systems (MES)
Laboratory Information Management Systems (LIMS)
Chromatography Data Systems (CDS)
Building Management Systems (BMS)
Environment Management Systems (EMS)
Learning Management Systems (LMS)
Document Management Systems (DMS)
Quality Management Solutions
Artwork Management Systems (AMS)
Warehouse Management System (WMS)
Enterprise Resource Planning Systems (ERP)
Supervisory Control and Data Acquisition system (SCADA)
Programmable Logic Controller (PLC)
Professional Experience: 3 - 7 years overall experience, with at least two years in the role of CSV Lead for computerized systems in GMP, GCP or GLP environment.
Address
Time: From 09:00 AMVenue: Technical Training Center, Survey No. 44, Bachupally, Qutubullapur Mandal, Bachupally Campus, Medak Dist 500 043
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