MANAGER - WAREHOUSE OPERATIONS
Zuellig Pharma
Remote
- 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.
- 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.
- Quality requirements
- 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.
- 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).
- 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.
- 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.
- Comparator sourcing.
- Ensure adequate resources are available for comparator sourcing.
- Ensure the turnaround and report to the Procurement team in a timely manner.
- 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.
- 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.