Qatar Petroleum Careers - QP Announced Government JobOpenings
صاحب العمل نشط
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكتروني
حالة تأهب وظيفة
سيتم تحديثك بأحدث تنبيهات الوظائف عبر البريد الإلكتروني
الوصف الوظيفي
The Technical Services Materials Specialist has primary responsibility in supporting the cGMP manufacture of biological bulk drug substance (BDS) at our clients facility in Blanchardstown, Dublin. The Technical Services Materials Specialist will be responsible for providing support for new material introduction to the Dublin facility, and will be required to work in close collaboration with Technical Services Technology Transfer Teams, Technical Services sustaining teams, Operations, Supply Chain, Quality, Quality Control and other involved departments to ensure successful introduction and qualification of new materials. The position is accountable for leading NMI workstreams to support projects and sustaining manufacturing and providing NMI expertise to support other functional groups.
To provide process expertise in:
- Materials: Acting as technical SME to support the selection and introduction of critical raw materials and single use components Providing technical leadership for material/component related issues, complaints, and investigations Liaising with Vendors to ensure they conduct adequate investigations and implement appropriate corrective actions when issues are identified
- To support the introduction of new raw materials and consumables through the generation of materials lists, Bills of Materials, material specifications and outline testing requirements To work closely with colleagues in Quality, Supply Chain and Manufacturing Operations to ensure availability and release of materials to meet technology transfer and routine manufacturing timelines Lead any key process changes using change control system Adherence to highest standards for Compliance (Quality and Safety), implement corporate standards and liaise effectively with global groups and provide technical support during audits Ensure compliance with site EHS policy, cGMP and other business regulations and participate in risk assessments, audits, and incident investigations To serve as a subject-matter expert (SME) on NMI and process support during regulatory agency inspections
Requirements
Skills:
Experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization Technical and operational knowledge of multiple unit operations in drug substance manufacturing Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings Ability to present and defend technical and scientific approaches in both written and verbal form Ability to drive for results independently and adapt to rapidly changing priorities Experience of Technology Transfer activities is advantageous Detail orientated Technical writing competency
Skills: Experience in Technical Services / Process Development / Manufacturing in a biological bulk drug substance manufacturing organization Technical and operational knowledge of multiple unit operations in drug substance manufacturing Comprehensive understanding of cGMP requirements for biopharmaceutical manufacturing Good interpersonal skills coupled with demonstrated ability to effectively work in a matrix organization, and in local group settings Ability to present and defend technical and scientific approaches in both written and verbal form Ability to drive for results independently and adapt to rapidly changing priorities Experience of Technology Transfer activities is advantageous Detail orientated Technical writing competency
نوع التوظيف
دوام كامل
القسم / المجال المهني
المهارات المطلوبة
