Takeda Pharmaceuticals QC Executive in WIC, Ireland
Are you looking for a patient-focused, innovation-driven company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a QC Executive in our Bray Plant in Co. Wicklow.
Takeda is a global pharmaceutical leader with more than 30,000 professionals working together across more than 70 countries. We have an unwavering dedication to put people first and we live our values of Takeda-ism: Integrity, Fairness, Honesty, and Perseverance. We are united by our more than 230-year legacy of research-based pharmaceuticals and our mission to strive toward Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals and intended for human use and a good working knowledge of manufacturing processes, packaging processes and validation activities used in the pharmaceutical industry. Good organizational, supervisory, technical writing and investigation skills are required.
•Responsible for the daily supervision of all Quality Control Laboratory functions
•Ensure that Production, QA, Planning and Shipping receive an effective quality service through meeting scheduled target release dates and compliance standards
•To ensure that the Manager; QC Laboratory is kept informed and up to date of the status of the QC laboratory
•To act as designee for Manager; QC Laboratory in their absence
•Supervision of Senior QC Analyst Groups and associated QC analysts
•Training, recruitment, motivation, discipline and performing appraisals of Senior QC Analysts and QC Analysts
•Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with regulatory expectation and cGMP
•Supervision of the quality control department resources (instruments and personnel) to provide a comprehensive analytical service for:
QC testing of raw materials / packaging materials/ intermediates / finished products/ clinical trial materials
Stability / Water
Technical Transfer / Validation of new and existing processes
•To carry out the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence
•Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times
•Member of the Self-Inspection Audit Team
•Assist in generation, implementation and control of QC annual budget for consumables, capital and headcount
•Review and Approval of relevant QC documentation
•To highlight and where necessary implement new technologies in QC area
•Preparing for and supporting external audits (HPRA, FDA, corporate, client).
Participate in the vendor certification programme as a lead auditor
•Support major Projects, quality initiatives and continuous improvement programmes within the department and in other functional areas
•Support the continuous improvement programme and projects within the QC laboratory
EDUCATIONAL REQUIREMENTS/RELEVANT EXPERIENCE:
BSc. (minimum) in science or related discipline.
Have relevant experience in the pharmaceutical industry.
5 years’ experience in an analytical lab preferable.
Technical experience of GC / HPLC Analysis required
Demonstrable experience managing, motivating and leading a team of analysts
Ability to promote teamwork by fostering a supportive and inclusive team atmosphere and To Focuses people on key priorities and guides them to achieve their goals
Ability to address performance issues on a timely basis and establishes specific plans to help team members reach objectives
Ability to provides team members with timely, constructive feedback, coaching and support to help them recognize and take action on their strengths and development needs
Ability to adapt to changing priorities
Good organizational, investigational & technical writing skills are required
Be a self-starter who is motivated & innovative
Desire to put people first and demonstrate the values of Takeda-ism
To further support and inspire our employees, our benefits include: Talent & Development Programme, Flexibility, Occupational Health & Wellness Programme, Company Events, Health Insurance, Pension, Paid Maternity/Paternity Leave, Educational Assistance Programme, Performance Related Bonus, Zero Absence Award, Onsite Parking, and Onsite Canteen.
Empowering Our People to Shine
Learn more at takedajobs.com.
Title: QC Executive
Requisition ID: 1800086