This organisation is a
manufacturer, marketer, and distributor of veterinary pharmaceuticals and animal health products.
Responsibilities
1.
Quality System Management
* Implement, maintain, and improve the
Quality Management System (QMS)
in accordance with
GMP (Good Manufacturing Practices)
,
VICH
,
FDA (21 CFR Part 210/211/226 for veterinary drugs)
,
EMA
, or
WHO
standards.
* Ensure compliance with
Veterinary Medicinal Product Regulations
and
Good Distribution Practices (GDP)
.
2.
Document Control
* Manage SOPs, batch records, specifications, and protocols.
* Ensure controlled distribution, versioning, review, and archiving of all QA documentation.
3.
Batch Record Review and Product Release
* Review batch manufacturing and packaging records for accuracy and compliance.
* Approve and release raw materials, intermediates, and final products for distribution.
4.
Deviation, CAPA, and non-conformance Management
* Investigate deviations, out-of-specification (OOS) results, or complaints.
* Initiate and track
CAPAs (Corrective and Preventive Actions)
and ensure timely closure.
Experience
* Bachelor's degree in a science related field.
* 2-3 years experience in a GMP environment.
* Knowledge of Good Manufacturing Practices (GMP) - especially veterinary GMPs.
* Knowledge of
FDA (CVM)
,
EMA
,
VICH
, and
USDA
regulatory requirements.
* Knowledge of GLP, GDP, and ISO standards (e.g., ISO 9001).
* Knowledge of Quality Management Systems (QMS).
To discover more about this opportunity please apply online or contact Darragh on for a confidential discussion.