...maintenance program, troubleshoot and resolve malfunctions, propose equipment solutions, report anomalies, ensure regulatory compliance (FDA, IMB, GMP, Safety, and Environmental legislation), and conduct onsite equipment calibration. By fulfilling these responsibilities THE...
...management will be a distinct advantage.
* Must possess knowledge of pharmaceutical and/or medical device regulatory requirement for FDA and IMB regulated environments.
* Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws....
Team Horizon
Galway
1 day ago
...metrics, e.g. NC, CAPA, Process Changes, , Quality Alert, Product Holds and Recalls.
Support site during External Audits. (i.e. FDA, IMB and BSI).
Responsible for input to Quality Metrics.
Ensure quality system updates
What you will need:
Degree Qualified...
...of the position.
· Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.
DESIRABLE:
· Experience in auditing of external suppliers, contractors and vendors
MUST ALREADY BE...
Kenny-Whelan & Associates
Ringaskiddy, Co. Cork
4 days ago
...standard at all times, this includes but is not limited to all notified bodies associated with the Tullamore plant, e.g. FDA, ISO, TUV, IMB, ENHESA, NSAI and IDA.
Ensure site production trainers fully trained and competent.
Developing best practices to reduce the...
...EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
Demonstrated knowledge and testing experience in an FDA/IMB approved QC laboratory.
NOTE: A waiver may be granted in exceptional circumstances for individuals who are not performing those...
Johnson & Johnson
Cork
2 days ago
...·Liaising with the waste brokers to ensure the timely shipment of all waste materials.
·Dealing with regulatory agencies (e.g. FDA, IMB, EPA and HSA) and auditors.
ABOUT YOU?
·The ideal candidate must have a primary degree in engineering or a science-related subject...
Cpl Healthcare
Dublin
1 day ago
...equipment in one or more of the following areas: Chemistry, Biochemistry or Microbiology.
~ Prior supervisory experience of working in an IMB/FDA regulated facility is a must have.
~ BSc in a scientific/technical field required
~ Advanced degree (MSc, MBA, PhD) preferred...
Johnson & Johnson
Cork
2 days ago