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

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

06 Aug
|
Aarvi Encon
|
Bhiwandi

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



Clients 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.

Attributes Required (Must-Have):

Required educational level

- Graduate/postgraduate in pharmacy or equivalent
- MBA in Logistics & Supply Chain Management is preferred

Required working experience

- 8-10 years in a similar operations management role in a pharma or clinical trial supplies storage facility.
- At least 5 years in a supervision / management position.
- Experience in liaising with Clients / external parties.
- Participated in operations improvement / implementation projects, preferably systems implementation.
- Experience in cold chain management preferred.
- Experience in establishing new Depo preferred.

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

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