Description

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.The Production Services Coordinator (PSC) is responsible for:<ul><li>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. </li><li>Development and procurement of labels and secondary packaging materials</li><li>The PSC will also lead pre-production planning activities including:</li><li>Coordination of SPARC meeting</li><li>Monitoring and management of pre-requisite materials required to enter production</li><li>Analysis and monitoring of data pertaining to shipment and packaging activities</li></ul> The PSC is the link between PM&D and PLD for pre-production on assigned projects.Key Accountabilities:General<ul><li>Coordinate delivery to meet the agreed production timelines</li><li>Comply with Quality standards, including applicable SOPs and GxP* standards</li><li>Maintain strong focus on external and internal client satisfaction</li><li>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</li><li>Coordinate study requirements from beginning to end</li><li>Perform on the job training for the departmental team</li></ul>Project Planning-Clinical Trial Supply Strategy<ul><li>Provide support for set-up/development of project specific logistics strategy</li><li>Provide input into development of documents, manuals and quality documentation including GMP relevant documentation</li><li>Provide input into vendor selection</li><li>Coordinate requirements with external groups including sponsor</li></ul>Project Execution and Control<ul><li>Develop manufacturing and packaging strategies with relevant stakeholders in line with GMP, GCP and other relevant regulations</li><li>Propose supply strategies based on study progress, adjust accordingly and provide feedback to depots</li><li>Propose package designs as required</li><li>Contribute to the Production Specification through consultation with depot and Quality stakeholders</li><li>Create Master Batch Records for packaging operations performed at PAREXEL depots</li><li>Issue Production Specifications and pre-execution batch records, ensuring first time quality of batch and expiry date information</li><li>Review and manage approval of production batch records from external Contract Manufacturing Organizations</li><li>Develop and purchase necessary packaging tools for use in PAREXEL depots</li><li>Review and manage approval of packaging tool specifications from external Contract Manufacturing Organizations</li><li>Develop label artwork and secondary packaging materials</li><li>Purchase materials from external vendors</li><li>Perform QC on the print proofs or package solutions provided by vendors, approve the final approach for production</li><li>Manage complaints following GxP guidelines</li><li>Coordinate purchasing, manufacturing, distribution, return, recall and destruction of medication for clinical trials, as applicable</li><li>Coordinate SPARC meetings</li><li>Monitoring and management of pre-requisite materials required to enter production</li></ul>Customer satisfaction and Client Liaison<ul><li>Actively engage external and internal clients in solution improvements</li><li>Act as point of contact for internal and external customers and use a consultative approach in issue resolution</li><li>Proactively engage with external and internal clients in solution improvements</li><li>Work towards establishing positive relationships with internal and external clients</li><li>Represent Parexel at professional meetings/conferences as participant and/or speaker</li></ul>Ensure Quality and Process improvement<ul><li>Support ongoing optimization of system infrastructure</li><li>Address and follow up on quality issues and CAPAs</li><li>Contribute to development and writing of applicable SOPs, worksheets and procedures</li><li>Prepare, participate in and follow up on audits/inspections</li><li>Implement process improvements, in conjunction with the team, in response to corporate, quality, client and team feedback and quality audits</li><li>Participate in meetings to identify process improvements & innovation topics</li><li>Capture identified metrics and present as appropriate</li></ul>Skills:<ul><li>Result-oriented, confident, self-motivated</li><li>Proficient in Microsoft Office (MS Excel)</li><li>Proficient in Adobe InDesign and Adobe Acrobat</li><li>Good analytical capabilities combined with creative problem-solving skills and a sense of urgency</li><li>Ability to prioritize workload</li><li>Decision making</li><li>Positive, objective, balanced, and result-driven</li><li>Organizational talent</li><li>Patience</li></ul>Knowledge and Experience:<ul><li>Solid understanding of Good Manufacturing Practice regulations</li><li>Experience in clinical logistics or related field within the biopharmaceutical industry</li><li>Experience in Packaging, Labeling and Distribution of IMPs and Non-IMPs</li><li>Practical understanding of the drug development regulatory and logistics framework</li><li>Basic understanding of financial tasks</li><li>Multinational work experience</li><li>Fluent in English</li><li>Minimum of 2 years’ experience in similar roles within the pharmaceutical industry – either with a sponsor or service organization</li></ul>Education:<ul><li>Vocational or Bachelor degree, or equivalent in biology, pharmacy or other health-related discipline, international trade or logistics business</li><li>Or relevant work experience / degree</li></ul>

Production Services Coordinator

Description

Parexel

Pipeline