Pharma Manufacturing Company : Sr. Manager QA&RA

Sakash Group

10 - 20 years

12 - 15 Lacs

mumbai

Posted:6 hours ago| Platform:

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Skills Required

medical devices iso performance management pharma analytical healthcare clinical research workflow senior manager qa hr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Extensive experience hosting regulatory inspections and interacting with regulators

Strong understanding of global registration requirements and demonstrated trackrecord of successful market access.
Experience with computer software validation (CSV) and implementation for QMSand ERP software packages, including user requirements gathering and specificationdevelopment, process workflow documentation, validation script writing, and IQ/OQ/PQ test case execution
General understanding of ICH, cGMP, cGDP, FDA, ISO, MDR, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices
Effective manager with ability to mentor and develop members of the QA/RAteams through coaching and effective performance management

Responsibility

Proven ability to create culture of accountability and ownership
Proven track record with establishing and maintaining strong internal and external partnerships.
Must be able to work effectively at all levels in the organization in a matrix environment and with external partners.
Must demonstrate excellent written and verbal communication skills and work well with diverse teams and stakeholders in multiple locations.
Must possess the ability to conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities to meet deadlines and prioritize work on multiple projects.
Highly independent and self-motivated and integrates well within a team. Physical Demands
Ability to travel.

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