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description de la société
Our client is a global biopharmaceutical company focusing on creating value for people living with neurology and immunology conditions.
description de la fonction
Do you have minimum 5 years experience working in the pharmaceutical/biologics industry in a quality management position? Then you are the person we are looking for!
Support to Product QA Stewardship & Strategy:
Ad hoc member of TST. Participation as requested
Provide QA support for commercial initiatives (projects) as requested
Support maintenance of detailed QA Product Flow Overview globally for assigned products
QA stakeholder for Product Risk management
Identify quality improvement needs for the assigned products and liaise with key stakeholders and management accordingly
Monitor key performance indicators (metrics) for key product QA activities and services associated
Provide support for regulatory inspections. Ensure and facilitate regulatory inspections related to the accountable products are well prepared and key stakeholders are available for support during the inspections. Support post inspection observation closure
Support to Commercial Product QA Operational Accountabilities:
Provide QA support for commercial activities as requested
Deputise as a Lead of Global Products Change Control Committee(s) as requested
Deputise as a Lead of Global Products Customer Complaints Committee(s) as requested
Periodic aggregation and trend analysis of product complaints; identification and implementation of CAPA
Oversee Annual Product Quality Reviews for accountable products. Review and approve Executive PQR Summary Reports for accountable products
Review and approve Product Stability Strategy for accountable products (for products where applicable)
Reviewer and approver of Specification for the accountable products in the case of external QP (for products where applicable)
QA reviewer and approver for all global Methods associated with the accountable products in the case of external QP (for products where applicable)
Maintain a Product Collaboration Site with Product QA Cockpit for the Products
Maintain a QA Cockpit for the Products (Quality Agreements, PQRs, audits, manufacturing chain and vendors, complaints, certificates, product contacts, change controls, recalls, launches,…)
Support to Development Quality Pharma Sciences Accountabilities:
Ensure the QA project support of the CMC process development and clinical supply including analytical work, manufacturing, review and release, technology transfer, CMC filing,… from early phase to commercial launch of the product.
Support the activities of CMC and Development QA Pharma Sciences for relevant quality systems (deviation close out / Change management/ complaints / quality improvement)
Ensure adequate documentation processes and systems are available and followed for CMC development projects (SOPs / Protocols review /approval)
Write Quality Assurance Agreement between CMO and Development Quality PharmaSciences
Work in accordance with UCB HSE and Corporate policy requirements and drive personal training and development activities to meet the needs of the business and professional career development
Deputise for Global Quality Leads when requested
Minimum of 5-8 years working in the pharmaceutical/biologics industry in a quality management position.
Good knowledge and understanding of Good Manufacturing Practices (GMP) Regulations and CMC Regulatory requirements
English : Advance level - which is the main day-to-day language required for this position. French language skills is an advantage
Must be able to act in most circumstances without direct supervision and handle complex situations.
Auditing expertise would be an distinct advantage
We offer an attractive salary with extra-legal advantages :