USP Manufacturing Compliance Specialist (Level III)
A speciality biopharmaceutical company is currently recruiting a USP Manufacturing Compliance Specialist (Level III) to join their office in Reykjavik. This organisation is renowned for its work on high-quality biosimilar products, ranging across the value chain from cell line development to commercial manufacturing. This is an exciting opportunity to work with a dynamic and upcoming company and bolster a career in the biosimilar space.
- To coordinate with Quality Affairs to ensure documentation readiness that will be used throughout the manufacturing facility during batches including batch records, logbooks, etc.
- To assist in Creation and review of important quality related biomanufacturing documents together with MSAT:
- Process Flow Diagrams & Bill of Materials
- Batch Production Records & Analytical Control Plan
- Standard Operating Procedures
- Analytical Procedures
- Material Specifications
- Product Specifications
- To provide technical oversight during biomanufacturing runs including troubleshooting and review and approval of quality documents such as planned changes, deviations and excursions
- To develop and maintain metrics to track batch record turnaround time, errors and document related deviations.
- To track all quality records (Deviations, Change Controls, CAPA etc..) to maintain the compliance
- To be responsible for ensuring all Manufacturing Documents are fully reviewed before submission to the Quality Assurance group.
- To contribute in post-run debriefs to prepare for next run(s)
- To provide assistance with CMC compilation for regulatory submission
- To assist in Development of customized manufacturing training programs geared towards complex unit operations through combination of classroom and hands on practice
- To collaborate with MSAT team regarding relevant documentation (PPQ, CPV, Technical Summary Reports) and provide quality oversight ensuring compliance to regulatory requirements.
- To be responsible for ensuring the USP suite and equipment is maintained in a state of Inspection readiness at all times.
- Collaborate with MSAT and contribute towards Technology Transfer of processes to manufacturing scale.
- Contribute as required to successful commercial Pre-Approval Inspections (PAIs), regular Audits and any other interactions with regulatory agencies.
- Adhere to the company etiquette in all matters of behaviour and manners.
Skills and Requirements:
- Knowledge of upstream fermentation activities to aseptically generate and proliferate mammalian cell cultures (in both production and lab scale) including hands-on expertise operating equipment including Bioreactors and Shakers.
- Knowledge of regulatory guidelines for biomanufacturing (FDA, ICH, PIC/s) and implementation.
- Minimum 2 years in compliance role for biomanufacturing, desired.
- Experienced in process and equipment validation activities.
- Experience of supporting Pre-Approval Inspections (PAI) and working with international regulatory agencies including the FDA and EMA.
- Expertise working with up-to-date cGMP compliance and associated documentation.
- Demonstrable project management skills.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Owen Bach at +44 203 826 1330 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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