Computer System Validation (CSV) -QMS For Pharma Company in Bangalore

From 8 to 10 year(s) of experience
₹ Not Disclosed by Recruiter

Job Description

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
Division: Pharma

Department: QA
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
Mobile: 8105301588
Email: zabi@bvrpc.com


Job Responsibilities:

  • 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.

Competencies:

Technical / Professional Knowledge

Problem Solving / Troubleshooting

Action Oriented

Attention to Detail

Multi-tasking

Building Relationships

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

Education

UG:B.Tech/B.E. in Any Specialization

Company Profile

BVR People Consulting

BVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - ‘The People’ and ‘The Processes’. It is our endeavour to facilitate this process of ‘Rejuvenating Organisations’ through a variety of customised, innovative and practical solutions that bring about positive attitudinal shifts, while driving organisations to re-assess their true potential. These solutions are designed based on a thorough ‘Diagnosis’ and ‘Need Audit’ of the organisation. We work with our clients as partners and a team. Our solutions are tailored for each client's unique needs and business context, and are designed to ensure that clients get the best return on their investment.
Company Info
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Recruiter Name:Mr Zabi Moghal

Contact Company:BVR People Consulting

Telephone:8105301588

Email:zabi@bvrpc.com

Address:#2831 ,2nd Floor, 15th Main, 2nd cross, E-Block, Sahakarnagar, BANGALORE, Karnataka - 560092,India|91-80-23532692

Website:http://careers.bvrpc.com