Job Reference: JO-2006-65255_1592908021
This position provides SME support and management of C&Q and validation activities on projects at their Cork site to assist internal stakeholders to meet current cGMP regulatory requirements and Company procedures as per HPRA expectations.
- Maintain and improve the commissioning, qualification, and validation systems within the company.
- Assist with risk assessments/change controls and deviations by providing input as a subject matter expert on behalf of validation.
- To lead and advise the validation of new/existing facilities, utilities, equipment, and processes and liaise cross-functionally on qualification & validation scheduling.
- To review and evaluate FAT/SAT/FS/URS/SDS/HDS documents and reports to ensure a good design basis is established for all validation studies.
- Generate, review, or execution of VMP/DQ/FQ/IQ/OQ/PQ/CV protocols/reports for equipment, facility, utility, process & computerised systems.
- Create/maintain the site validation master plan or validation project plans when necessary.
- Manage external contractors in accomplishing validation project tasks when required.
- Create/maintain validation/engineering department related SOPs and WI documents.
- Implement and complete engineering/validation related CAPA and deviation actions.
- Use site Quality Management System software.
- Maintain knowledge of current validation cGMP practices as per HPRA and EMA.
- Implementation of the Cleaning Validation program within the company
- Implementation and coordination of the annual re-qualification studies i.e. temperature mapping or air quality testing executed by external contractors.
- Minimum qualification of a bachelor's degree in a scientific/technical discipline required
- 3-5 years' experience working with validation and qualification projects within GMP regulated environments.
- Experience in contributing to GMP management systems such as change control/deviations/risk assessments.
- Understanding of various validation concepts i.e. thermal/sterilization/facility/cleaning/equipment etc.
- Strong understanding of API manufacturing.
- Experience working across a Global business a distinct advantage.
- Skilled in the execution of Risk Assessment and the use of a variety of problem-solving techniques
- Experience in projects, audits & inspections as Validation SME.
- LEAN and Six Sigma philosophy are embedded in your day to day working.
- Enjoy working closely with your stakeholders and have a hands-on operational approach to Validation.
- A good communicator and when collaborating on a given task you contribute with a positive and constructive attitude.
- Work independently with a strong personal drive.
- Strong attention to detail and organisational skills with a quality-focused mindset.
- Could critically assess issues and devise and execute appropriate solutions by decisively using problem-solving techniques.
- Strong business mindset.
- Travel may be required as part of the role.
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