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Sakash Group
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Pharma Manufacturing Company : Sr. Manager QA&RA

Pharma Manufacturing Company : Sr. Manager QA&RA

Sakash Group

10 - 20 years

12 - 15 Lacs

mumbai

Posted:9 hours ago| Platform:

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Skills Required

medical devices iso 13485 iso performance management gcp pharma analytical clinical research healthcare

Work Mode

Work from Office

Job Type

Full Time

Job Description

MBA is a plus Experience:

Bachelor s degree required in a science, engineering field or related discipline.

10 years of QMS experience and demonstrated leadership experience.

Proficiency with ISO 13485, Good Clinical Practices (GCP), and Quality SystemInspection Techniques (QSIT); CFR s parts 210 &211.

Skills & Abilities:

Strong understanding of global registration requirements and demonstrated trackrecord of successful market access.

Extensive experience hosting regulatory inspections and interacting with regulators

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 track record with establishing and maintaining strong internal and external partnerships.

Proven ability to create culture of accountability and ownership

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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