Cache of job #14169823

Job Title

Senior Quality Specialist






An amazing opportunity has arisen as a Senior QA Specialist in the site Quality team, this senior role leads a team in the API and Drug Product Intermediate Process IPT (Integrated Process Team. What skills you will need: In order to excel in this role, you will more than likely have: The Senior Quality Specialist (POD Lead) is a self-directed, decision maker who is responsible for the management and oversight of the Quality Management Systems in the Drug Substance and Drug Product Intermediate facilities and for the achieving the Quality deliverables in the Integrated Process Teams (IPTs) ensuring that the site meets all Manufacturer’s Licence requirements for clinical and commercial production and is audit ready for both customers and agency inspections. Uses sound judgement to make good decisions based on information gathered and analysed. Responsible for providing leadership and guidance on site-wide quality assurance and regulatory compliance.  Team Leadership: is accountable for the development and performance of the Quality Specialists in the IPT Quality POD team. The Quality Leader mentors the team, providing input and coaching on professional development, provides timely feedback and ensures that responsibilities are delivered in line with appropriate inclusion principles & behaviours. Teamwork skills: Interacts with people effectively. Able and willing to share and receive information. Sets and maintains high performance standards. Pays close attention to detail, accuracy and completeness. Excellent written and oral communication and interpersonal skills. Organizes and delivers information appropriately. Adapts to changing work environments, work priorities, organizational needs and diverse people. Motivation: Displays energy and enthusiasm. Maintains high level of productivity and self- direction. Previous Experience. Knowledge of Quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT, Quality Docs. Knowledge and demonstrated expertise in Lean / Continuous Improvement. Proven Leadership Skills. Experience and knowledge of GMP Requirements for Electronic/paper free operations. Experience in High potency manufacturing / Spray drying / Laboratory GMP / Project Management is desirable. Degree or post-graduate qualification in Science, Pharmacy or equivalent. Eligible to act as a Qualified Person, desirable but not essential. What you will do: Bring energy, knowledge, innovation and leadership to carry out the following: As a site SME for batch disposition, lead the API / Drug Product Intermediate quality release activities and deliver system continuous improvement. Lead the API Quality Specialist team to ensure timely and effective completion of the Quality IPT core functions, including; Application of Quality Risk Management to all process and systems. Production support and quality compliance guidance to ensure the facility meets and operates to all GMP requirements for development, clinical and commercial supply. Assist the IPT leadership team to deliver business results for the IPT in line with overall site goals . Documentation preparation, review & approval process required to support IPT operations. Prepare Annual Process and System Reviews. API & Drug product Intermediate raw material (API, SDI and excipient) and component release, targeting. API & SDI batch review and release and deviation management process, Ensure that all Laboratory Out of Specification (OOS) and process deviations are documented, assessed and associated CAPA identified. Provide support to deviation investigations and process performance monitoring. Perform trending on deviations raised as required to identify improvement initiatives. Provide detailed knowledge of quality systems and ensure that root cause is identified and corrective actions as appropriate are completed. Provide guidance on quality requirements to maintain validation status, including participation in process/product Risk Assessments. Ensure changes controls raised are documented, assessed and completed. Participate in the generation and communication of quality metrics. Preparation, review & approval of site documentation including policies, procedures, associated reports and annual reviews, as required to support site quality systems. Participation in the internal audit program. Participate in the preparation for and hosting of regulatory and customer audits. Participate in Quality and site projects that may arise. Participate as a team member in the site new product introduction teams established to manage the transition of new products from Phase II2 through to PPQ and supply.  Delegate for the API Associate Quality Director as required. As a company, we are committed to ‘Inventing for Life’ in all that we do. We keep the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.  We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. So, if you are ready to: Invent solutions to meet unmet healthcare needs, Impact the future by driving one of the world’s leading healthcare companies, and inspire your team to reach their full potential and push the boundaries of science and technology, please apply today.  .

Date Added

54 days ago