JOB PURPOSE:

To work within the Quality Control Department to help maintain quality standards throughout the company. The brief requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.

RESPONSIBILITIES:

• Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice. Implement and maintain standards of GLP practice consistent with regulatory expectation and cGMP.
• Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management and the execution of business processes to a high standard as monitored.
• Support your team and help them to perform to a high standard, in the achievement of the company and department goals.
• Inspire enthusiasm and stimulate interest and guiding staff to ensure they are productive.
• Safety, cGMP and Continuous Improvement.
• Ensure that Production, QA, Planning, Shipping and support departments receive an quality service through meeting scheduled target release dates and compliance standards.
• Training, recruitment, discipline and performing appraisals of QC analysts/technicians.
• To perform an investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
• Validation, operation, maintenance, calibration and trouble shooting of laboratory instruments.
• Approval of relevant QC documentation
• Support major Projects, quality plans and continuous improvement programmes within the department and in other.
• Prepare for and supporting external audits (HPRA, FDA, corporate, or client).
• Implement and maintain standards of safety to guarantee a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe.
• To highlight and implement new technologies in QC area.
• To maintain the validated status of the LIMS/Empower systems and other relevant systems and to manage them to assure compliance with acceptable regulations and company policies.
• Support of Annual Product Reviews
• To act as designee for QC Department Head in their absence.

GENERAL RESPONSIBILITIES:

• Participate fully in any cross functional training initiatives.
• Drive and promote the corporate values of Takeda-ism within the workplace.
• Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business. Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an events
• Ensure timely completion of all SOP, reading, training and assessment.
• Other duties as required and directed by the Manager, Compliance or other Officer appointed by the Board of Directors.

EDUCATIONAL REQUIREMENTS:

• BSc. (minimum) in science or a related discipline

RELEVANT EXPERIENCE:

• A minimum of 5 years experience in an analytical lab preferably with supervisory responsibilities.
• Technical experience of GC / HPLC Analysis required.
• Experience with continuous improvement plans within the QC environment.
• Experience managing, motivating and leading a team of analysts

SKILLS/COMPETENCIES:

• Promote teamwork by promoting a supportive and inclusive team atmosphere and to focus people on priorities and guide them to achieve their goals
• Address performance issues and establish specific plans to help team members reach goals
• Provide team members with, constructive feedback, coaching and support to help them recognize and on their strengths and development needs.
• Good investigational and technical writing skills.
• Be a self starter who is willing to learn.

• Strong Interpersonal & communication skills.

• Problem solving capability.
• Good organisational skills.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine:

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, or any other characteristic protected by law.