Production Services Coordinator

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