Opportunity For QA Executive - Sandu Brother Pvt Ltd

Sandu

2 - 5 years

1 - 3 Lacs

mumbai thane navi mumbai

Posted:3 weeks ago| Platform:

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Skills Required

capa process validation ipqa change control bmr review risk assessment bpr review mfr

Work Mode

Work from Office

Job Type

Full Time

Job Description

Position: QA Executive

Job Location:

Working Days And Time:

Key Responsibilities:

Preparation and implementation of Standard Operating Procedures and Documentation like preparation of
MFR, BMR, BPR,
all types of
Validation, Stability study protocols and reports.
To implement and enforce cG.M.P. as per statutory requirements
Giving feedback to management regarding discrepancies, deviations and any special matter.
To attend external official work, seminars, meetings, discussions as per requirement of the organisation and to prepare and submit reports of the same
To meet with all requirement of FDA and related assignments such as product approvals, replying FDA queries and ensure efficient liasoning with the FDA authorities.
Analyse and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements
Monitor risk-management procedures, and maintain, analyze problem logs to identify and report recurring issues to management and product development.
Provide training and support to quality assurance team on systems, policies, procedures, and core processes
Document internal audits and other quality assurance activities
Identify training needs and organize training interventions to meet quality standards
Evaluate audit findings and implement appropriate corrective actions
Responsible for document management systems
Assure ongoing compliance with quality and industry regulatory requirements
Teamwork

Interested candidates can revert on same or can share their updated resume on hrd2@sandu.in

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