- Reference: GY43592
- Job Type: Permanent
- Location: Limerick
- Category: Bio-Pharmaceutical
As QA-Validation Specialist you will be responsible for the development and execution of steam in place sterilization and sanitization of process equipment. Implementation of company policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standards.
- Generates, executes, reviews, approves, master and completed qualification/validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
- Prepares equipment for qualification studies, executes qualification and validation studies according to approved protocols and SOPs.
- Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
- Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
- Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
- Initiates, reviews, edits and approves change control and SOPs
- Coordinates with other departments or outside contractors/vendors to complete validation tasks.
- Trains/advises less experienced Specialists and Technicians.
- Day to day management and oversight of sterilization contract specialists.
- Assesses quality system documentation for completeness and accuracy, and dispositions documentation per SOPs.
- Manages projects and prepares status reports.
Skills, Experience and Qualifications:
- Requires a BEng/BSc in Engineering, Chemistry, or Life Sciences with 6+ years of related experience within the field; will substitute relevant experience for education. Qualification/validation experience required.
- Ability to comprehend regulatory requirements and technical documentation.
- High level of emotional maturity and self-confidence.
- Extensive experience in Steam Sterilization of biopharmaceutical process equipment.
- Strong knowledge of cGMPs for biotechnology.
- Excellent written and oral communication skills.
For a confidential discussion and more information on the role/company email your CV to: firstname.lastname@example.org