Quality Specialist is required for a global Biopharmaceutical company in Cork.
The Quality Specialist will:
- Provide to the IPT knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Deviation/NOE/LIR coaching; GCM coaching, environmental monitoring program, etc.
- Support all quality and compliance requirements for the Integrated Process Team (IPT) to enable batch disposition for each batch manufactured.
- Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
- Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality.
- Provides compliance contribution to project teams and leads small projects.
- Ensure supply of high quality product through the implementation and oversight of the Quality Management System for the site.
- Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
- Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
- Liaises with Corporate Quality, as required, to ensure alignment and execution on actions related to Quality Systems and/or Operational Quality at the site.
- Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow-up actions where applicable.
- Ensure the highest Quality, Compliance and Safety standards.
- Works with other sites to aid them and ensure alignment and best practices adopted for Quality System related topics and/or Operational Quality.
- The Quality Specialist will participate and comply with the MMD Quality Management System (QMS) requirements, including ownership.
The Quality Specialist requires:
- At least 5 years' experience in the Pharmaceutical, Biopharmaceuticals industry or a similar operating environment which includes a minimum of 2 years' experience in a Quality Assurance/Quality Control function.
- Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science etc.)
- Operational experience of at least 4 QMSs and SME in at least 2 QMSs
- Degree in Science, Engineering or similar
- Lean Six Sigma Yellow Belt or suitable alternative
- Quality Assurance SME knowledge, from both operational and educational experience
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Aoife Gleeson in LSC on 021 4777 329 to discuss this new Quality Specialist role in more detail or apply directly via this advert.