Mgr/Sr Mgr - CSV - IT Validation - Pharma

We Having a good opportunity with a Leading Pharma Company for Gurgaon and Taunsa (Punjab) Location.

Designation - Manager /Sr. Manager

Job Profile:

- Work as part of project team to plan, monitor & review all validation & quality deliverables of the project to ensure compliance with SOPs & regulatory requirements (such as 21CFR Part11) to ensure timely closure of project

- Developing validation plan’s and review relevant documents ensuring product/project functionality is validated and documented across releases

- Provide input to validation planning for projects; Write technically sound computer system validation protocols while adhering to company procedures and regulatory expectations

- Provide tactical direction and guidance for changes to regulated computer systems and infrastructure

- Approves validation deliverables and system changes as defined in procedures

- Identify simplification and continuous improvement opportunities within projects

- Manage validation and/or qualification aspects of several projects simultaneously

- Evaluate project against regulatory and IT Risk requirements to ensure compliance

- Create gap analysis and mitigation plan to close the gaps

- Provide the link between the scientific communities, IT team and any third party regarding software functionality, throughout the development/implementation lifecycle.

- Would ensure that all relevant SOPs and processes are followed

- Will ensure that all deviations from the approved Validation SOPS are justified

- Will ensure that the project/change control is on track from a compliance perspective

- Validation will NOT author most documents, except assisting the team in authoring documents such as the Change Request, Validation Master Plan and Validation Report

- Conduct Validation / SOP training whenever necessary

- Collaborate with Quality Assurance – CSC team

Competencies Required:

Technical Competencies:

Pharma, GAMP, Validation Experience

Experienced in FDA / ICH regulations in regulated environments, such as 21 CFR Part 11

IF INTERESTED KINDLY MAIL ME YOUR UPDATED PROFILE.

Nidhi Dhyani
Synergy Consultants