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 strong 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 Specification through consultation with depot and Quality stakeholders
- Create Master Batch Records for packaging operations performed at PAREXEL depots
- Issue Production Specifications and pre-execution batch records, ensuring first time quality of batch and expiry date information
- Review and manage approval of production batch records from external Contract Manufacturing Organizations
- Develop and purchase necessary packaging tools for use in PAREXEL depots
- Review and manage approval of packaging tool specifications from external Contract Manufacturing Organizations
- Develop label artwork and secondary packaging materials
- Purchase materials from external vendors
- Perform QC on the print proofs or package solutions provided by vendors, approve the final approach for production
- Manage complaints following GxP guidelines
- Coordinate purchasing, manufacturing, distribution, return, recall and destruction of medication for clinical trials, as applicable
- Coordinate SPARC meetings
- Monitoring and management of pre-requisite materials required to enter production
Customer satisfaction and Client Liaison
- Actively engage external and internal clients in solution improvements
- Act as point of contact for internal and external customers and use a consultative approach in issue resolution
- Proactively engage with external and internal clients in solution improvements
- Work towards establishing positive relationships with internal and external clients
- Represent Parexel at professional meetings/conferences as participant and/or speaker
Ensure Quality and Process improvement
- Support ongoing optimization of system infrastructure
- Address and follow up on quality issues and CAPAs
- Contribute to development and writing of applicable SOPs, worksheets and procedures
- Prepare, participate in and follow up on audits/inspections
- Implement process improvements, in conjunction with the team, in response to corporate, quality, client and team feedback and quality audits
- Participate in meetings to identify process improvements & innovation topics
- Capture identified metrics and present as appropriate
Skills
- Result-oriented, confident, self-motivated
- Proficient in Microsoft Office (MS Excel)
- Proficient in Adobe InDesign and Adobe Acrobat
- Good analytical capabilities combined with creative problem-solving skills and a sense of urgency
- Ability to prioritize workload
- Decision making
- Positive, objective, balanced, and result-driven
- Organizational talent
- Patience
Knowledge And Experience
- Solid understanding of Good Manufacturing Practice regulations
- Experience in clinical logistics or related field within the biopharmaceutical industry
- Experience in Packaging, Labeling and Distribution of IMPs and Non-IMPs
- Practical understanding of the drug development regulatory and logistics framework
- Basic understanding of financial tasks
- Multinational work experience
- Fluent in English
- Minimum of 2 years experience in similar roles within the pharmaceutical industry either with a sponsor or service organization
Education
- Vocational or Bachelor degree, or equivalent in biology, pharmacy or other health-related discipline, international trade or logistics business
- Or relevant work experience / degree
