Batch Documentation Coordinator

Job Purpose:

The Batch Documentation Coordinator (BDC) 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.

The BDC takes responsibility to ensure GMP documentation is available to meet production timelines.

The BDC is the link between the CTS-Operations group and PLD for pre-production and the main contact for packaging batch records.

The BDC works closely with Label Design, internal and external depot staff relating to primary and secondary packaging operations, the Qualified Persons / Responsible Pharmacists and other Quality Management personnel.

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

• Create the Production Manual 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

• 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

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

QualificationsSkills:

• 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 / degreeEEO DisclaimerParexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.