A Technical Specialist is required by CareerWise Recruitment for our Cork based pharmaceutical client. This is a 12 month contracting position. If you have worked as Technical Specialist or Technical Scientist or in a Validation role this is the position for you !!!
THE ROLE
- Actively lead / support process microbiological investigations.
- Perform routine area walkdowns / GEMBA’s.
- Support and drive strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene through the promotion of a culture of continuous improvement and open communication.
- Perform Risk Assessments for operations projects and business innovation initiatives
- Define specific aseptic techniques to be performed for crucial process steps
- Support periodic review of environmental monitoring and in-process sampling trends and identifies appropriate corrective and preventative actions as required.
- Provide effective and timely communication of any adverse trends or activities as appropriate.
- Achieve individual goals through actively working with departments and individuals
- Maintain customer focus to deliver business requirements.
- Collaborate with Process Microbiologists internally and across the network
- Access global microbiology support resources, as required.
- Review and approve relevant SOP’s and WI’s.
- Participate in the planning for future requirements in Operations.
- Ensure microbiological control strategy is consistent with GMP requirements and company requirements.
- Participate in relevant internal and external manufacturing related audits.
- Understand and support current regulatory trends and future testing requirements.
REQUIREMENTS:
- BSc in a scientific/technical discipline required. Ideally microbiology discipline
Minimum of 3- 5 years of experience within a pharmaceutical or GMP regulated Operations environment. - Possess knowledge and experience of the shop floor manufacturing process.
- Possess knowledge of data analytics
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Please call Louise Mulligan today for further information on 0949003979 or email: lmulligan@careerwise.ie
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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