Company Overview

Role Purpose

We are seeking a Senior Associate to support Process Validation and Cleaning Validation activities for pharmaceutical manufacturing operations. The successful candidate will be responsible for validation lifecycle management, execution of validation protocols, data analysis, and ensuring compliance with GMP and regulatory requirements.

Academic Stream

Work experience

5 years

Job Responsibility and key Decisions

Key Responsibilities

• Prepare, review, and execute Process Validation and Cleaning Validation protocols and reports.

• Support qualification and validation activities for manufacturing processes

• Analyze validation data and identify trends to ensure process consistency and product quality.

• Investigate validation deviations and implement appropriate corrective and preventive actions (CAPA).

• Collaborate with Manufacturing, Quality Assurance, Engineering, and other cross-functional teams to support validation activities.

• Ensure validation documentation is maintained in accordance with GMP requirements.

• Support change control, risk assessments, and continuous improvement initiatives.

• Participate in regulatory inspections and audits related to validation activities.

Requirements

• Bachelor's Degree in Biotechnology, Pharmaceutical Science, Chemistry, Engineering, or any related field.

• Experience in Process Validation, Cleaning Validation, or Validation within the pharmaceutical, biotechnology, or medical device industry or food industry

• Good understanding of GMP, validation lifecycle, risk management, and regulatory requirements.