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.