Assistant Manager - Quality Assurance

Venus Remedies (VRL); Solan; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Venus Remedies (VRL) invites applications for a Quality Assurance role focused on QMS & GMP compliance, deviations, CAPA lifecycle, change control, market complaints, and data integrity. The candidate will lead internal audits, vendor qualification, and QRM activities to ensure product quality and regulatory readiness.

The role emphasizes training management, CAPA effectiveness, and continuous improvement within a GMP environment, with a focus on risk-based decision making and regulatory

Qualifications

• Experience in managing a QMS program and GMP compliance.
• Ability to review and approve Deviations, OOS/OOT, and investigations.
• CAPA initiation, verification, and lifecycle management.
• Change Control assessment, review and implementation.
• Handling Market/Product Quality Complaints with investigations.
• Prepare and approve SOPs, specifications, protocols, and reports.
• Conduct internal audits and regulatory readiness activities.

Responsibilities

• QMS and GMP compliance oversight.
• Deviations, OOS/OOT handling and investigations.
• CAPA lifecycle initiation and effectiveness verification.
• Change control assessment and implementation.
• Market and product quality complaint handling and investigations.
• SOPs, specs, protocols, and reports preparation/review.
• Internal audits and self-inspections, compliance monitoring.
• Vendor qualification and quality agreements management.
• QRM using FMEA and risk matrices.
• Quality metrics trending and management reviews.
• Regulatory inspection readiness and response management.
• Data integrity compliance and GMP documentation reviews.
• Training management and effectiveness evaluation.
• Support for PQR/APQR processes.
• Continuous improvement initiatives and quality culture enhancement.

Skills

QMS & GMP compliance

Deviation review

OOS/OOT investigations

CAPA lifecycle management

Change control assessment

Market complaints handling

Root cause analysis

Risk assessment

SOPs/specifications/protocols

Internal audits/self-inspections

Vendor qualification

Quality Risk Management (QRM)

Regulatory inspection readiness

Data integrity compliance

Training management

PQR/APQR support

Continuous improvement

Tools

FMEA

Risk assessment matrices

Job description

Role & responsibilities

QMS & GMP Compliance, Deviations, OOS/OOT & CAPA, Change Control Management, Market Complaints, Root Cause Analysis, Risk Assessment

Preferred candidate profile

• Management of Quality Management System (QMS) activities.
• Review and approval of Deviations, OOS, OOT, and Incident investigations.
• CAPA initiation, effectiveness verification, and lifecycle management.
• Change Control assessment, review, and implementation.
• Handling and investigation of Market Complaints and Product Quality Complaints.
• Preparation, review, and approval of SOPs, specifications, protocols, and reports.
• Internal audits, self-inspections, and compliance monitoring.
• Vendor qualification and quality agreement management.
• Quality Risk Management (QRM) using tools such as FMEA and risk assessment matrices.
• Management Review meetings and quality metrics trending.
• Regulatory inspection readiness and response management.
• Data integrity compliance and GMP documentation review.
• Training management and effectiveness evaluation.
• Support for product quality reviews (PQR/APQR).
• Continuous improvement initiatives and quality culture enhancement.