17 Aug
|
Zuellig Pharma
|
Bhiwandi
17 Aug
Zuellig Pharma
Bhiwandi
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, Positive Documentation Practices.
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.
Project Management
Provide guidance to the team, and especially to Project Coordinators while setting up current projects/ new projects for GMP.
Ensure the valuable 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.
Liai
📌 Manager Warehouse Operations Bhiwandi
🏢 Zuellig Pharma
📍 Bhiwandi