Production Services Coordinator
Primary Location: India, Hyderabad Additional Locations: India, Remote Job ID R0000038216 Category Clinical LogisticsAbout this Role
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
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