Applications <span style="color: #000080;"
Applications are invited for the position of QA Analyst for
a fixed term contract.
To work within the Quality Assurance 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.
Key Areas of Responsibility:
- Quality Review of Batch Records
- To assist in the investigation into non-conformances, participate in root cause analysis and carry out quality review of non-conformances
- Preparation and revision of cGMP documentation, Annual Product Reviews, Standard Operating Procedures, Product specification etc. within the QA Department as required.
- Support the site Quality Management systems including; the Deviation and CAPA Management systems, Change Control system, Internal Auditing programs, GMP Training, Customer Complaints and the Vendor Management program.
- Participate in and facilitate continuous improvement projects as required
- Member of the Self-Inspection Audit Team
- Participate in cross-functional training provided by QA
- Control/storage of retain samples, including periodic retain inspection
- Presenting GMP Training to Takeda employees
- Drive and promote the corporate values of Takeda-ism within the workplace
- Any other duties as required and assigned from time to time by the Senior Director of Quality or any other officer appointed by the Board of Directors
The successful candidate will have:
- BSc (minimum) in a Scientific Discipline is essential
- Quality Assurance Experience working in the pharmaceutical Industry is desirable
- Experience in Solid Oral Dosage is desirable
- Excellent verbal and written communication skills
- Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements.
Applications for this position must include an up to date CV and should be submitted via the Employment Opportunities Page on the Company Website www.takeda.ie on or before 4th March 2013. Please do not submit hard copy CV’s as unfortunately they will not be accepted.
Takeda Ireland Limited is an Equal Opportunities Employer