Main purpose of role:

To ensure process validation activities at the contract manufacturer has been carried out as per current GMP standards and best industry practices in line with Marketing Authorisations (MA).

To obtain and review existing process and analytical method validation reports from Contract manufacturer and ensure they meet current GMP standards.

To highlight gaps identified in existing validation reports and work with relevant departments / contract manufacturer on remediation plan to mitigate the risk.

Stay updated on recent changes in guidelines and ensure ADVANZ PHARMA’s Operations Systems and procedures comply with current legislation as and where applicable.

To participate in preparation of monthly metrics and support in presenting the team KPIs wherever needed

To participate in Quality improvement projects.

Key responsibilities (In Points):

Maintain and lead the activities for the planning and implementation of any analytical and / or process validation master plans for all MA’s held by the company.





Review and approve process validation protocols and reports for upcoming projects (Development / Technology Transfer / Product Lifecycle Management changes) and ensure SOP is followed throughout the process.

Perform detailed validation gap analysis of process and analytical method validations across the range of products under company portfolio as per relevant SOP.

Highlight any discrepancies / gaps identified in the existing validation, risk assess the identified gaps and propose and lead appropriate remediation activities by liaising with internal / external business partners to close the actions on time.

Support delivery of specific projects as Quality representative for site transfers, API dual sourcing, reformulation, and process improvements.

Based on Formulation / production experience, able to take decisions for any issues to be resolved during process validation batches, no. of batches to be taken based on product know-how an

📌 Specialist, Validation (Mumbai)
🏢 AdvanzPharma
📍 Mumbai