Assistant Manager - Validation & Qualification

Role & responsibilities

The Assistant Manager Validation will be responsible for the planning, execution, and documentation of validation and qualification activities. This role ensures compliance with regulatory requirements and internal quality standards. The individual will work closely with cross-functional teams, including Quality Assurance, Production, and Engineering, to validate processes, equipment, and systems critical to injectable product manufacturing.

Key Responsibilities:

1. Validation Execution:

• Develop and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes used in injectable manufacturing.
• Conduct validation studies for critical systems, including aseptic processes, sterilization, cleaning, and packaging equipment.
• Execute computer system validation (CSV)

2. Qualification Activities:

• Perform qualification of equipment such as autoclaves, filling machines, oRABS, HVAC systems, water systems (WFI and purified water), and other critical utilities.
• Oversee thermal mapping and validation of cold storage units, stability chambers, and warehouses.

3. Protocol Development and Review:

• Prepare and review validation protocols, reports, and summary documents.
• Ensure all validation documentation meets regulatory and company standards.

4. Compliance and Regulatory Adherence:

• Ensure compliance with Good Manufacturing Practices (GMP), ISO, FDA, and other global regulatory requirements during validation activities.
• Support regulatory inspections and audits by presenting validation data and documentation.

5. Continuous Monitoring:

• Establish systems for continued process verification (CPV) to ensure ongoing compliance of validated systems and processes.
• Analyze trends and deviations in validation performance and recommend corrective actions.

6. Training and Supervision:

• Train team members and operators on validation protocols, procedures, and regulatory requirements.
• Supervise and guide validation technicians during protocol execution.

Preferred candidate profile

Experience:

• 5-7 years of experience in validation/qualification activities in a sterile injectable manufacturing environment.
• Extensive experience with aseptic processes, sterilization validation, and equipment qualification.
• Skills and Competencies:
• Expertise in preparing and executing validation documentation (IQ, OQ, PQ, and CSV).
• Proficient in using validation software tools and Microsoft Office Suite.

Preferred candidate profile