MANAGER - WAREHOUSE OPERATIONS (India)

1. Operational Management

· Oversee daily operations in the Warehouse, Project Management, Production team.

· Managing the secondary packaging & labelling activities of the assigned Projects, support the Production, Project Management

· Ensure availability of equipment and their validation/calibration for the proper storage of Clinical Trial Material (CTM) as required.

· Oversee vendor qualification, vendor management and vendor performance evaluation for warehouse and production.

· Ensure control of the CTM and plan the GMP activities as per the client requirements.

· Ensure timely completion and review of batch packing records, processing for QA checks and obtain the Client approval.

2. Resources & Training

· Ensure adequate resources are provided to conduct Operations in a timely manner for below:

· Standard Operations Procedures

· Staffing within FTE Budget

· Effective training

· Capacity Management to achieve operational goals

· Follow ICH-GCP, WHO Guidelines, GxP, Good Documentation Practices.

3. Quality requirements

Ensure all Operations activities are conducted in line with:

· Regulations (DCGI), GMP, GCP, GSDP

· Requirements (ZP regional guidelines, SOPs, DPIs, agreements)

· Safety measures

· Client's requirements

· Support for Client audits

· Manage Non-Conformance, deviation, identify root cause and implement CAPA.

4. Project Management

· Provide guidance to the team, and especially to Project Coordinators while setting up new projects/ new projects for GMP.

· Ensure the good management of all protocols/studies and overall, Client's requests satisfaction.

· Supervise the documentation and filing of operational documents (DPI, Inbound, Outbound, labelling, return, destruction, BPR, production etc).

· Supervise and prioritize the actual processes (Inbound, Outbound, labelling, return, destruction, etc).

5. External Communication

· Lead and drive communication with Client for project management.

· Liaise with Client for problem solving or issue escalation.

· Liaise with Vendors and work towards cost-efficient supplier management.

6. Data analysis and reporting.

· Provide reports and data analysis on a regular basis (monthly reports).

· Oversee the reporting process and ensure Clients receive agreed reporting in a timely manner with blinding consideration.

· Drive accuracy of SAP Data and reporting.

7. Comparator sourcing.

· Ensure adequate resources are available for comparator sourcing.

· Ensure the turnaround and report to the Procurement team in a timely manner.

8. Depot Support

· Support Country Head, Clinical Reach India in various ad-hoc projects.

· Management of the Operational Teams, ensure all activities meet timelines and escalate issues as required.

9. Continuous improvement

· Develop SOPs and work toward a constant process improvement.

· Actively identify and propose solutions to issues as they arise and implement them with stakeholder approval and engagement.