Role: Computerized Systems Validation (CSV)
CSV Lead for computerized systems in regulated environment.
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.
Authoring/reviewing SOPs relevant to Computerized Systems Validation.
Perform system risk assessments, systems gap analysis, review and approve action plans to ensure compliance during and after the system validation
Help, guide and direct the project manager during the system implementation and validation process, and ensure compliance with corporate policies and procedures.
Provide training related to computerized systems validation, quality and compliance to users and appropriate personnel.
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.
Review change controls and perform periodic reviews
Establish and implement corrective actions and preventive actions where appropriate, and process improvement initiatives.
Face regulatory, customer, IT Quality System related inspections for all computerized systems across the Formulation units
Expert knowledge on implementing
a.21 CFR Part 11 / Eudralex Vol.4 – Annex 11 compliance
b.Quality Management and Information Security standards
Proven expertise in the validation of two or more of the following systems
a.Process analytical technology (PAT)
b.Manufacturing Execution Systems (MES)
c.Laboratory Information Management Systems (LIMS)
d.Chromatography Data Systems (CDS)
e.Building Management Systems (BMS)
f.Environment Management Systems (EMS)
g.Learning Management Systems (LMS)
h.Document Management Systems (DMS)
i.Quality Management Solutions
j.Enterprise Resource Planning Systems (ERP)
k.Supervisory Control and Data Acquisition system (SCADA)
l.Programmable Logic Controller (PLC)
Self-starter and Team player, able to work independently and with teams.
A good communicator with a structured approach to every activity
Good presentation skills
Educational Qualification: Btech (Electronics & Telecommunication or Instrumentation), M.sc (Physics or Electronics) or MCA or equivalent.
Professional Experience: 8-10 years overall experience, with at least 4-5 years in the role of CSV Lead for computerized systems in GMP, GCP or GLP environment.
Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: IT Software – System Programming
Role Category: Team Lead/Technical Lead
Role: Team Lead/Technical Lead
computerized system validation
Education:UG -B.Tech/B.E. – Any Specialization, Electronics/Telecommunication, Computers, Instrumentation
PG – M.Tech – Any Specialization, Computers, Electronics/Telecommunication, MCA – Computers, M.Sc – Any Specialization, Computers, Electronics, Physics
Doctorate – Any Doctorate – Any Specialization, Doctorate Not Required
Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com
Recruiter Name:Venkat Vishwanath
Contact Company:Dr Reddys Laboratories Ltd