Job
Description
Expectations of the Role: 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 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. 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 Client’s / external parties. Participated in operations improvement / implementation projects, preferably systems implementation. Experience in cold chain management preferred. Experience in establishing new Depo preferred. Advantage to Have: Required knowledge & skills Knowledge of supply chain management and shipping management. Planning and organization skills. Good managerial and people development skills. Independent thinking, ability to adapt and manage effectively in fast paced environment. Experience in planning, assessing, and implementing projects. Solid business acumen accompanied by interpersonal savvy. Excellent communication and analytical skills Resourceful, self-driven, proactive. Show more Show less
