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Home
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Venus Remedies (VRL)
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Quality Assurance - QMS ( Injectable Plant)

Quality Assurance - QMS ( Injectable Plant)

Venus Remedies (VRL)

4 - 7 years

4 - 6 Lacs

Baddi

Posted:3 weeks ago| Platform:

Apply

Skills Required

Capa Market Complaints QMS Documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

QMS Implementation & Oversight:

Maintain and continually improve QMS elements such as
deviation handling, change control, CAPA, OOS/OOT, risk assessments, and quality reviews
.
Ensure compliance with
GMP, GAMP, ISO, ICH (Q9, Q10), and regulatory agency requirements (e.g., USFDA, MHRA, WHO, EU GMP)
.

Deviation & CAPA Management:

Investigate deviations in manufacturing, QC, and support areas.
Perform
root cause analysis (RCA)
and drive timely and effective CAPA implementation.
Monitor the closure timelines and effectiveness verification of CAPAs.

Change Control & Document Control:

Evaluate and manage changes in equipment, facility, process, and documents.
Review and manage controlled documents including
SOPs, protocols, risk assessments
, etc.
Ensure document lifecycle management in compliance with
GDP
.

Audit Readiness & Regulatory Compliance:

Support internal audits, regulatory inspections, and third-party audits.
Prepare and maintain
audit documentation, observation responses, and compliance tracking
.
Coordinate
self-inspections and site quality risk assessments
.

Training & Quality Culture:

Conduct GMP training programs related to QMS and quality culture.
Monitor training compliance across functions and maintain training matrices.

APQR/PQR & Quality Metrics:

Participate in the preparation of
Annual Product Quality Reviews (APQRs)
.
Compile, monitor, and report
Quality KPIs
and metrics to management.

Sterile Manufacturing Support:

Ensure QMS processes support sterility assurance practices.
Review and ensure compliance for media fill protocols, aseptic area controls, and environmental monitoring deviations.

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