BVR People Consulting Looking for IT scientific application at Bengaluru, Karnataka Full Time

Roles and Responsibilities IT scientific application :
:

15- 18 years of Experience in managing, implementing and supporting all GxP systems across Quality, RnD in Pharma industry

Key Competencies:
Expertise in implementing, maintaining and supporting various Quality and RND systems and

Advanced understanding and hands on experience with the following GXP applications and tools :

LIMS– Laboratory Information Management System for API, Formulation & Biologics Quality Control

eLN– Electronic Laboratory Notebook for Biologics R&D

VLMS– Validation Lifecycle Management System for Equipment & Computerized System Validation

NuGenesisSDMS – CDS & Non-CDS raw data archival solution

Chromatography DataSystem(CDS)-Waters’ Empower, Agilent’s OpenLab Chemstation & ECM and Thermo’s Chromeleon across R&D and QC handling multiple location, function and old data migration.

Stability & EM Module (LIMS) across API, Formulation & Biologics Operations.

eCTD– docuBridge/eValidator for regulatory submission

Knowledge of GxP regulations and guidance documents pertaining to Documents, Training, Deviations, CAPA, Change Control, and/or Records Management

Regulatory Requirements- Regulatory & ISO Standards like GAMP5, 21 CFR Part 11, ISO 27001:2013 and risk management, corporate policies, and procedures

KEY RESPONSIBILITIES

Lead and support all GxP (Quality, Rnd) projects implementation and continuous improvement, ensuring projects are appropriately and adequately defined

Develop plans and lead teams to execute and support all GxP projects and systems

Collaborate and communicate successfully with cross-functional customers and partners to improve user experience

Lead the administration and support team for all GxP system activities including configuration, workflow management, user access management, periodic reviews and documentations.

Remain current on trends and new technologies and developments in areas of responsibility

support in generation/review/approval of computer system validation deliverables

Support Audits and inspections conducted by internal and external agencies

Support site and function audit preparations with respect to system functionality.

Assist in user training and support training delivery.

Drive and/or support improvement efforts and on-going maintenance of Systems by identifying gaps, proposing potential solutions, and supporting the implementation of improvement initiatives

Interested candidates share your cv to [email protected]

Role:Other Salary: Not Disclosed by Recruiter Industry:Pharmaceutical & Life Sciences Functional AreaOther Role CategoryOther Employment Type:Full Time, Permanent

Key Skills

LIMSeCTDLeadershipCDSChromeleonNuGenesiseLNGxP systemsmanagingimplementing and supportingIT Management

Education UG:Any Graduate

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.

Job Detail

Job Id

JD2391670

Industry

Not mentioned

Total Positions

1

Job Type:
Full Time

Salary:
Not mentioned

Employment Status

Permanent

Job Location

Bengaluru, Karnataka, India

Education

Not mentioned

Experience

Year