Production QMS – Executive /Sr Executive

Caplin Steriles Pvt Ltd; Thiruvallur District; On-site; INR 6,00,000 - 8,00,000; Full time

Job summary

A leading pharmaceutical company in Thiruvallur District is seeking a quality assurance professional. The candidate must have a Bachelor's degree in Pharmaceutical Sciences or a related field and 3-5 years of experience in pharmaceutical manufacturing. Key responsibilities include root cause analysis, cGMP compliance, and product quality assurance. SAP proficiency is essential for this role and offers an excellent opportunity for growth.

Qualifications

• 3-5 years in pharmaceutical manufacturing or quality assurance.
• Strong analytical and communication skills required.
• Proficiency in SAP is necessary.

Responsibilities

• Conduct root cause analysis and corrective actions.
• Ensure cGMP compliance and training development.
• Review batch records and maintain clean room standards.

Skills

Analytical skills

Communication skills

SAP proficiency

Regulatory compliance knowledge

Education

Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, or related field

Tools

SAP

Job description

Key Responsibilities:

• Root Cause Analysis
• Corrective Actions
• Change Control
• CAPA Effectiveness
• OOS/OOT Investigations
• cGMP Compliance
• Training & Development
• SOP Preparation
• Batch Records Review
• Status Labeling
• In-Process Control
• Clean Room Maintenance
• Validation Coordination
• Core Activity Monitoring
• Inter-Departmental Coordination
• Production Planning
• Regulatory Audits
• SAP Transactions

Qualifications Required:

• Education: Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, or related field.
• Experience: 3-5 years in pharmaceutical manufacturing or quality assurance.
• Skills: Strong analytical and communication skills, proficiency in SAP, and knowledge of regulatory compliance.