This a Full Remote job, the offer is available from: India 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: • 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 This offer from "Parexel" has been enriched by Jobgether.com and got a 82% flex score.