Quality Assurance Manager @ Invitro Research

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Quality Assurance Manager

Invitro Research
4 - 5 Years
Bengaluru
5 years ago
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Job Description

Position : Manager Quality Assurance
Experience : Min 5 years in a CRO, managing QA profile. Exposure in a GMP setup is also desirable
Job Responsibility :
Lead / Manage Quality Assurance department
Responsible for Quality Assurance processes of Clinical Development and Analytical Laboratory
Act as a Management representative of the organization in all the external- regulatory & customer audits, certification bodies and sponsor representatives on matters relating to the quality system.
Manage Quality Management System and ensure its implementation to all the stake holders.
To review the Manuals, Standard Operating Procedures, and other quality documents.
Responsible for Internal audits (technical and quality systems), follow-up action, reviewing of corrective actions
To ensure there is no break in Accreditation Cycle.
Planning regulatory trainings.
Ensures that MRM is conducted as per the requirement (timeline and agenda).
Review, monitoring and data compilation of customer complaints (Customer complaints- to register the complaint received from customer and coordinate the root cause analysis and conclude on Corrective and preventive actions.
To review and approve master list of SOPs.
Handling of Accreditation/ regulatory Bodies and recognition (regulatory queries, follow up and compliance).
Responsible for review of all management system documents in-coordination with Lab Managers.
Monitoring the implementation of Management system and review deviations from the same.
To oversee the activities with respect to Quality Management Systems, Archives and Learning and Development.
Reporting to the management of iVRS on the performance of the quality systems and need for improvement

Employement Category:

Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Quality Control
Role Category: Head
Role/Responsibilies: Quality Assurance Manager

Contact Details:

Company: Invitro Research
Location(s): Bengaluru

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Preferred City (* max. 2 w/comma)

Designation / Expected Role

Current / Recent Company (*)

Experience (*)

Expected Salary (*)

Desired Industry (*):

Functional area / Department (*):

Enter Skills (key skills, subjects, technologies & roles to use in search)

Write briefly about yourself, your experience and education (*)

Attach ResumeMax 2.38 MB (RTF, PDF, DOC, DOCX formats only parsed)

Please, check the file size and type.

Add social media [ + ]

Create password

I agree with website service terms and conditions

Invitro Research

CRO

Quality Assurance Manager @ Invitro Research

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