Validation Technician - 6 month contract
Junior Validation role to support validation project in our Deansgrange site. The contract is for a minimum of 6 months and flexibility around hours may be required.
Principal Duties and Responsibilities:
· Execute Qualification and Validation projects, to ensure new equipment and processes are operational on time and existing equipment and processes remain in a validated state
· Preparation of validation documents / protocols (VMP’s, URS, RTM, DQ, IQ, OQ & PQ)
· Execution of Validation activities.
· Adhere strictly to regulatory, cGMP, Standard Operating Procedures, Policies & any other rules defined by the Company
· Deviation / Non- Conformance management (Including RCA & CA/PA) for validation activities
· Maintain a suite of Metrics and KPIs, to provide direction and reporting information for teams and management in the area of Validation.
· Participating in and contributing to Baxter team projects and initiatives as required
· Partaking in regulatory, corporate and internal audits as required & ensuring validation documents are in a state of “audit readiness”.
Qualifications and Experience:
· Basic Science, Engineering or Pharmacy qualification
· Demonstrate knowledge and understanding of the requirements of the position
· Validation experience minimum of 1 year required (execution & report writing)
· Experience in Isolator technology & Sanitisation (desirable to not essential)
· Demonstrate skills in problem-solving, system design, application of GMP knowledge
· Logical, practical-minded with a hands-on approach
· Creative, analytical, innovative,
· Self-motivated and able to motivate others
· Shows good judgment to achieve a balance between cost:benefit, quality and safety
· Able to communicate effectively, written and oral
· Able to manage effectively resources and time