Roles and Responsibilities
Job Title: Computer System Validation (CSV) -QMS
Company: Leading Pharma Company in Bangalore Location
Designation: Assistant Manager
Reporting to: Head IT (CSV)
No. of Positions: 1
Location: Bangalore Location
Qualification: B.Tech (Computer science, Automation / EC / CS)
Years of Experience: 8 to 10 Years
Salary Range: 10 to 14 LPA
Contact person: Mr.Zabi Moghal
- Must have ability in determining business system requirements; regulatory understanding of FDA, MHRA and other key regulations.
- Must have detailed knowledge in various OS and Softwares used for data & system security in pharmaceutical companies.
- Must have knowledge in managing the infrastructure for enterprise resource solutions like SaaS based applications, ERP, eQMS, eDMS, Production platforms etc.
- Must have experience and knowledge about Pharmaceutical Quality Management Systems (Deviation, Change Controls, CAPA, QRM) and its application in IT systems
- Must be able to coordinate multiple validation and qualification activities with project teams, various departments, and external vendors. These activities include Installation Qualification (IQ); System Testing, which covers Operational Qualification (OQ), Performance Qualification (PQ), Regression testing; Backup and Restore; Disaster Recovery; Data Migration; and upgrades introduced through change control.
- Must have proficiency in SOQL, SOSL , SQL & relational databases
- Must be able to conduct Risk Impact Assessment (RIA), Validation Risk Assessment and 21 CFR Part 11 Assessment.
- Must be able to create a User Requirements Specification, and assist in the creation of a Functional Requirements Specification and the Technical Design Specification for IT infrastructure required for production and non-production systems.
- Must be able to review all System Delivery Life Cycle (SDLC) deliverables, and ensure that the deliverables adhere to associated Standard Operating Procedures (SOPs) or Working Procedures (WPs).
- Must be completely proficient in all Information Technology SOPs and WPs and possess a thorough understanding of computer system validation in order to be capable of approving all System Delivery Life Cycle (SDLC) deliverables
- Must be able to create, review, and update SOPs and WPs associate with SDLC.
Knowledge, Skills & Abilities:
- Understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
- Knowledge and understanding regulatory requirements, including ISPE GAMP5, 21 CFR part 11, Annex 11 and other harmonized international guidelines (PIC/S, ICH) and GxP. Direct experience with 21 CFR Part 11 compliance.
- Demonstrates multi-tasking ability.
- Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion.
- Written and verbal communication skills along with presentation skills.
- Proficient at writing well-formulated emails and reports.
- Ability to follow oral and written instructions relevant to the assigned task.
- Ability to effectively communicate with employees, contractors and vendors.
- Highly proficient in Microsoft Office Suite – Word, Excel and Outlook, and the innate ability to learn new software as required for computerized system qualification.
Technical / Professional Knowledge
Problem Solving / Troubleshooting
Attention to Detail
Education & Experience:
- Degree in Engineering (Computer science, Automation / EC / CS) preferred.
- 8-10 years of experience in IT technology, IT system management, IT operations for FDA-regulated industry, with experience in CSV.
- Knowledge of pharmaceutical laboratory and process systems; Experience with Biologics equipment preferred.
Role:Cloud System Administration
Salary: Not Disclosed by Recruiter
Industry:Pharmaceutical & Life Sciences
Functional AreaIT & Information Security
Role CategoryIT Infrastructure Services
Employment Type:Full Time, Permanent
UG:B.Tech/B.E. in Any Specialization
BVR People Consulting
Recruiter Name:Mr Zabi Moghal
Contact Company:BVR People Consulting
Address:#2831 ,2nd Floor, 15th Main, 2nd cross, E-Block, Sahakarnagar, BANGALORE, Karnataka - 560092,India|91-80-23532692