About This Job Co-ordination of the QC labs on a day-to-day basis in terms of technical and operational decisions and workflow.Review and approval of test results.Management of GMP practices within the QC Lab.Trouble shooting test issues.Responsibility for resolving equipment/software issues.Responsible for Laboratory Investigations and Non-Conformance lead investigation and management within Test Team.Analytical equipment expert.Responsible for GMP inspections, QC internal audits, housekeeping, presenting QC during audits.Mentor and coach chemists and analysts within team.Responsible for ensuring Team members are appropriately trained.
Responsible for Training program in QC Including planning, coordinating training requirements and reviewing completed training.Preparation of test schedules, management of tracker boards and associated tracker board meetingsCommunicate and contribute to Value Stream on behalf of QC.Day to day management of Team resources in the allocation of daily assignments in order to meet business requirements.
Annual appraisals of and regular one on ones with all those involved in assigned Team.Trending of QC Analytical data.Maintain QC Stability Testing Program.Management of QC calibration schedule.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 the Lead Pharma Manu Quality Control DPEssential Knowledge & Experience1 – 2 years' experience leading a team is an advantage.Thorough knowledge of GMP, Pharmacopeia and regulatory requirements.Makes suggestions for improvement, new initiatives, ways to minimize costs and challenges current ways of work to improve efficiency.Ability to work effectively on own.Ability to co-ordinate and communicate effectively with the QC Leadership team.
Good team management and leadership skills.Lean six sigma skills, ability to handle data and to use data to make day to day decisions.Proven problem-solving skills.Good planner.Analytical chemistry know-how and desire to increase technical skill and knowledge.Analytical Equipment expert.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.