Operations Manager(Pharma Warehouse and Clinical Trail) (Bhiwandi)

Operations Manager(Pharma Warehouse and Clinical Trail) (Bhiwandi)

13 Aug
|
Aarvi Encon
|
Bhiwandi

13 Aug

Aarvi Encon

Bhiwandi

OPENING FOR AN OPERATIONS MANAGER (PHARMA WAREHOUSE)

Purpose of the Role:
- The Operations Manager is responsible for the warehouse operations of Receipt, Dispatch, Returns and Storage in a GMP facility.
- Manage areas with the current responsibility of approx. 10 FTEs accountable for Operations, Order Processing, Facilities Maintenance, Project Management, secondary packaging & labelling activities.

Expectations of the Role:

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
- Clients 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 current projects/ new projects for GMP.
- Ensure the good management of all protocols/studies and overall, Cli

📌 Operations Manager(Pharma Warehouse and Clinical Trail) (Bhiwandi)
🏢 Aarvi Encon
📍 Bhiwandi

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