The brief requires a thorough knowledge of Good Manufacturing Practice, & current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use. Strong background in regulatory compliance is highly desirable. Strong organizational, supervisory and leadership skills are required. A high level of initiative, project management skills and good verbal and communication skills are essential. Good technical writing skills are also required.
- Maintenance and control of GMP documents within facility
- Coordination and submission of regulatory documentation
- Oversight of Regulatory Compliance requirements
- Oversight of Quality Systems requirements
- Management of regulatory and customer requests
- Preparation (as required), Management and review of quality systems documentation- Standard Operating Procedures, Specifications, Guidelines, Protocols, etc.
- Management of specific GMP Quality Systems as required in accordance with the EU GMPs, FDA, requirements & ICH guidelines
- Support other TIL departments on Quality Issues as required
- To assist in audit preparation for regulatory and customer audits and to act as a member of the audit team as required.
- Communication and liaison with other TIL departments
- 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 event.
- Ensure timely completion of all SOP, reading, training and assessment.
- Other duties as required and directed by the relevant Manager or Site Quality Head
- Primary Degree in Scientific discipline
- Have a minimum of 5 years experience in the pharmaceutical industry, preferably in a Quality role
- Regulatory Compliance experience is highly desirable
- Ability to promote teamwork by fostering a supportive and inclusive team atmosphere and to focus people on key priorities and guide them to achieve their goals
- Ability to address performance issues in a timely basis and establishes specific plans to help team members reach objectives
- Ability to provide team members with timely, constructive feedback, coaching and support to help them recognise and take action on their strengths and development needs
- Ability to adapt to changing priorities
- Good organisational, investigational & technical writing skills are required
- Be a self starter who is motivated & innovative
Fixed Term (Fixed Term)