About This Job Perform analysis of in-process, raw material, final product, and stability samples.
Ability to interpret the raw data and results generated, document and report as per written procedures as per schedules in accordance with cGMP and all other regulatory requirements.
On completion of analysis, perform independent data review of all analysis as per schedule.
Reporting and documenting of results must be completed accurately and promptly and in accordance cGMP and all other regulatory requirements.
Sampling of raw materials & process /purified water.
To carry out the qualification, maintenance, and calibration of QC Instrumentation as per schedules ensuring relevant KPI's are met.
To troubleshoot problems which occur when using instruments and to implement solutions to avoid re-occurrence.
Support effective root cause analysis and timely closure of investigations.
Improve laboratory RFT through use of effective root cause analysis and CAPA actions and improve analytical testing processes.
Develop, revise, and implement procedures to comply with appropriate regulatory requirements.
To execute instrument and method validation protocols in accordance with written procedures.
To partake in QC team meetings and team activities and attend plant meetings as required.
Support/participate in Analytical Method Transfer and other validation projects.
Support/participate in OpEx projects in QC and on site.
Support laboratory stock inventory.
To communicate any non-conformance, instrument malfunction, accident or near miss to immediate supervisor.
Work with management and staff to foster an ethos and culture of safety awareness, where safety is accepted as an integral part of the overall business.
Ensure compliance with relevant regulations and standards associated with cGMP including data integrity, ISO 14001, ISO45001, Health & Safety Legislation, Environmental Legislation, and also all site standards, policies, and procedures.
Other issues as directed by QC Team Lead and Lead Pharma Manu Quality Control DP.
Expectation to support weekend and bank holiday overtime rotating schedule to ensure continuity of production.
Flexibility for ad-hoc testing of production samples.
Essential Knowledge & Experience Third level qualification in science or equivalent discipline, with minimum experience of working in a QC position.
Ability to co-ordinate and communicate effectively with the QC Leadership team.
Good collaboration skills.
Thorough knowledge of GMP, HPLC experience, Pharmacopeia, and regulatory requirements.
Lean six sigma skills, ability to manage data and to use data to make day to day decisions.
Makes suggestions for improvement, new initiatives, ways to minimize costs and challenges current ways of work to improve efficiency.
Show leadership, planning and problem-solving skills.
Analytical chemistry knowledge and desire to increase technical skill and knowledge.
Understanding and ability to perform audit preparation and inspection.
Good management of stakeholders across key interfaces.
Good training and coaching skills.
Excellent organisational, interpersonal, and technical writing skills.
Good Presentation skills.
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.Our expertise, science and technology make us a pharma company.
Our open and progressive culture is what makes us Astellas.
It's a culture of doing good for others and contributing to a sustainable society.Delivering meaningful differences for patients is our driving force.
We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience.
At Astellas, Patient Centricity isn't a buzzword - it's a guiding principle for action.
We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.#IJA