Quality Specialist CMO応募 後で応募 求人ID R0014410 掲載日 11/14/2019 Location:Dublin, Ireland
The Quality Specialist is a member of the Quality Assurance team who supports QP Certification of drug product at Takeda Ireland Limited Grange Castle (TILGC).
The scope includes Drug Substance, Drug Product and Finished Drug Product.
In accordance with business needs, the Quality Specialist may assume responsibilities in any work area of the TILGC Quality Department.
As with all site personnel, the Quality Specialist is responsible for promoting a culture of Regulatory Compliance and Continuous Improvement within the Quality Department and across the TILGC site.
The responsibilities of the Quality Specialist include the following:
- Quality representative on the External Supply team working collaboratively with the cross functional team and CMO to facilitate supply of product to our patients according to Takeda SOPs and GMP standards
- Quality oversight of contract manufacturers; leading, monitoring and supporting the performance of quality systems according to GMP standards which consists of, but not limited to, change controls, deviations, CAPAs, complaints, documentation and material supplier management.
- Participation as the Quality Assurance representative in Material Review Boards, CMO Quality Reviews and Supply planning.
- Management and review of CMO Batch Manufacturing Records (BMRs).
- Resolution of quality related topics and escalate where further input required
- Generation of Key Performance Indicators within the Quality Assurance area to align with company and global quality objectives.
- Participation in the Global Audit programme of CMOs.
- Taking a leadership role in promoting a culture of Compliance, Right First Time and Continuous Improvement.
- Implementing efficiency improvements in Quality Dept on a continuous basis and participating in site projects and initiatives.
- Communication and liaison with other Takeda sites on Quality issues (as required), providing guidance and support to others.
- 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 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 other Officer appointed by the Board of Directors.
- Primary Degree in a scientific discipline
- Minimum of 4 years’ experience in the pharmaceutical industry in a Quality role, preferably experience relating to CMO oversight.
- Experience of oral solid dosage manufacture preferable.
SKILLS / COMPETENCIES:
- Excellent knowledge of Good Manufacturing Practice as described in current FDA & EMEA regulations for oral solid dosage pharmaceutical manufacture.
- High level of initiative.
- Excellent verbal and written communication skills.
- Strong project management and organisational skills.
- Ability to adapt to changing priorities.
Grange Castle, Ireland