16 Aug
|
Zuellig Pharma
|
Bhiwandi
16 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, Good 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 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.
- Liai
📌 MANAGER - WAREHOUSE OPERATIONS (Bhiwandi)
🏢 Zuellig Pharma
📍 Bhiwandi