Quality Assurance Specialist
QA Manufacturing Specialist
QA Manufacturing Specialist is required for a new purification and aseptic filling plant for the blood protein albumin at Grifols Worldwide Operations (GWWO).
Reporting directly to the QA Manufacturing Supervisor of Grifols Worldwide Operations (GWWO).
To complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the aseptic manufacturing operations in Grifols Worldwide Operations Ltd (GWWO).
Extensive knowledge and understanding of Annex 1 and aseptic regulatory requirements is essential.
1.1 Act as a delegate for the quality supervisor when required
1.2 Act as a representative for the Quality team in the absence of the quality supervisor/manager
2.1 Daily briefing on Quality batch review/approval
2.2 Provide quality performance information as required
2.3 Ensure regular Quality interaction with other Departments
3 Quality Assurance Activities:
3.1 Support method transfer plans, qualification of sampling plans for water systems, raw materials, environmental monitoring, in- process and FP testing
3.2 Sampling of raw materials, water, clean compressed air, steam
3.3 Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
3.4 Reviewing and approving SOP's, validation protocols and reports and other GMP documentation
3.5 Review of Batch Records
3.6 Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
3.7 Ensure that general cGMP programs are delivered and maintained effectively at GWWO
3.8 Conduct, report and display of Quality audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
3.9 Lead and/participate in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area
3.10 Maintain a high level of technical writing expertise and stay current with regulatory trends
3.11 Conduct internal GMP audits and support the continuous improvement initiatives and regulatory requirements for quality monitoring
3.12 Support the spot check/walk-through process of the area
3.13 Involve in customer complaint investigation if required
3.14 Support the annual product quality reviews if required
3.15 Act as back room support during any external audit/inspections
3.16 Represent Quality in the project management for any Process/product/system improvement projects
3.17 Training of new Quality personnel where appropriate and development of new training
3.18 GMP implementation and site-wide Quality Awareness
3.19 Liaise with other Department representatives to promote improvements in GMP and Quality standards
3.20 Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the Grifols sister sites
3.21 Keep abreast of the latest developments from regulatory authorities in relation to Quality Compliance activities and highlight to management of any changes that potentially impact GWWO
- Excellent communication skills
- Competence in Microsoft packages specifically word, excel and PowerPoint
- Good organizational skills
- Results orientated
- Ability to make decisions
- Deep knowledge and understanding of the aseptic regulatory requirements
- Minimum of B.Sc Degree and at least 5 years' experience in a quality or production function within the aseptic pharmaceutical/medical devices industry
For more information Contact Ann Marie Corcoran