The Production Services Coordinator (PSC) is responsible for:
- The pre-production activities relating to batch documentation, labeling and GMP flow to ensure all production materials are produced to meet the timelines following SOPs, applicable ICH-GxP* and other applicable industry & regulatory guidelines to meet or exceed client expectations.
- Development and procurement of labels and secondary packaging materials
- The PSC will also lead pre-production planning activities including:
- Coordination of SPARC meeting
- Monitoring and management of pre-requisite materials required to enter production
- Analysis and monitoring of data pertaining to shipment and packaging activities

The PSC is the link between PM&D; and PLD for pre-production on assigned projects.

Key Accountabilities:
General
- Coordinate delivery to meet the agreed production timelines
- Comply with Quality standards, including applicable SOPs and GxP* standards
- Maintain robust focus on external and internal client satisfaction
- Represent Production Services at internal project meetings,



Support the teams on a global basis in labeling and packaging, introduce our services and the business unit on the global level
- Coordinate study requirements from beginning to end
- Perform on the job training for the departmental team

Project Planning-Clinical Trial Supply Strategy
- Provide support for set-up/development of project specific logistics strategy
- Provide input into development of documents, manuals and quality documentation including GMP relevant documentation
- Provide input into vendor selection
- Coordinate requirements with external groups including sponsor

Project Execution and Control
- Develop manufacturing and packaging strategies with relevant stakeholders in line with GMP, GCP and other relevant regulations
- Propose supply strategies based on study progress, adjust accordingly and provide feedback to depots
- Propose package designs as required
- Contribute to the Production Spec

📌 Production Services Coordinator (Hyderabad)
🏢 Parexel
📍 Hyderabad