Sr. eCompliance Specialist

NOVARTIS

5 - 10 years

20 - 25 Lacs

hyderabad

Posted:-1 days ago| Platform:

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Skills Required

operational support project management operations management team management training facilitation servicenow operations itsm incident management compliance application support negotiation project delivery communication skills itil

Work Mode

Work from Office

Job Type

Full Time

Job Description

Point of Contact for all CSV related matters for GxP Computerized Systems and act as an interface between IT and Business for eCompliance topics in relation to GxP classified Computer Systems promoting a Quality Culture.
Review and approve project related documents for GxP relevant systems including determination of GxP applicability for all GxP and non-GxP relevant systems.
Establish trusted partnership with assigned IT Function with understanding of business drivers, and provide the needed day to day operational support.
Review and approve the GxP impacted deviations, ensure appropriate CAPA are implemented.
Contribute for the preparation of VMP and execute the plan for the systems associated with the respective functions.
Review and approve the Periodic Review Reports for the GxP computerized systems and the associated gaps within CAPA Management System.
Perform supplier qualification assessment activities
Provides audit support as assigned and in case of CAPAs, provides the required Quality support.

Key performance indicators:

GXP r e l e v a nt c o m p u t e r iz e d s y s t e ms a r e d e v e l o p e d, i m ple me n t e d a nd m a in t a i n e d a cc o r di n g t o t h e N o v a r tis r e q u i r e m e nts.
On time review and approval of changes, deviations & periodic review reports for the GxP computerized systems.
D o c u m e n t a ti o n s u p p o r ting e C o m p li a n c e a nd C SV r e q u i r e m e nts is in pl a c e , m a in t a i n e d u p - t o - d a t e a nd c a n be p r e se nt e d d u r ing a u d its a nd i n s p e c ti o ns wit h o ut d e l a y s a nd i ss u es .
G a ps in e C o m pl i a n c e a nd C SV a c ti v iti e s a r e p r oa c ti v e ly i dentif i e d , e s c a l a t e d a nd t h e d e v e l o p m e nt o f miti g a t i o n pl a ns s u p p or t e d . C li e n t / s t a k e h o l d e r sati s f a c ti o n a nd cor r e s p o n d i ng f e e d b a ck .

Minimum Requirements:
Work Experience:

5-10 years of overall experience, and a minimum 4 years of relevant experience in the Pharmaceutical Industry within particular in regulated functions such as IT Quality and Compliance

Skills:

Good understanding of global regulations and Health Authorities expectations governing computerized systems (CSV, Part 11, etc.)
Good experience in the development, implementation and lifecycle management of computerized systems in regulated environments
Experienced in the operational management of GxP solutions including its related technologies to support the operation
Experience in GxP supplier qualification activities
Good understanding in system application management, its Quality support approach and industry best practices (ITIL, ITSM, etc.)
Experienced in the development, implementation and lifecycle management of key computerized systems in the Pharmaceutical Development, Manufacturing, Quality, Commercial and Infrastructure space
Successful cross-divisional/functional work with complex international teams
Ability to adjust to multiple demands, shifting priorities and unexpected events while maintaining a positive work attitude
Ability to effectively interact and present to Management
Ability to influence without hierarchical authority and build trusted partnerships
Self-starter with experience in initiating and delivering projects and processes
Excellent communication, negotiation, facilitation, and interpersonal skills

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