Quality Assurance Specialist Biotech

Quality Assurance Specialist Biotech

Quality Assurance Specialist is required for a new purification plant for the blood protein albumin.
This role offers a chance to work in a state of the art facility, in an innovative Biotechnology company with excellent career development opportunities and a clear and committed patient focus.
You will be required to complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the manufacturing operations

QUALIFICATIONS & SKILLS

· Excellent communication skills
· Competence in Microsoft packages specifically word, excel and PowerPoint
· Good organizational skills
· Flexibility
· Results orientated
· Ability to make decisions
· Minimum of B.Sc Degree or equivalent third level education and at least 5 years' experience in a quality or production function within the aseptic pharmaceutical/medical devices industry

RESPONSIBILITIES
Act as a delegate for the quality supervisor when required
Act as a representative for the Quality team in the absence of the quality supervisor/manager
Daily briefing on Quality batch review/approval
Provide quality performance information as required
Ensure regular Quality interaction with other Departments
Act as a delegate for the quality supervisor when required
Act as a representative for the Quality team in the absence of the quality supervisor/manager
Daily briefing on Quality batch review/approval
Provide quality performance information as required
Ensure regular Quality interaction with other Departments
Reviewing and support method transfer plans, sampling plans for water systems, raw materials, environmental monitoring, in- process and FP testing
Sampling of raw materials, water and in-process samples
Reviewing and approving SOP's, validation protocols and reports and other GMP documentation
Review of Batch Records
Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
Ensure that general cGMP programs are delivered and maintained effectively
Conduct, report and display of Quality audit readiness metrics weekly to ensure continuous audit readiness and cGMP compliance
Lead and/participate in technical deviations, investigations, CAPA and change controls and provide Quality support to the manufacturing area
Maintain a high level of technical writing expertise and stay current with regulatory trends
Conduct internal GMP audits as lead auditor and support the continuous improvement initiatives and regulatory requirements for quality monitoring
Support the spot check/walk-through process of the lines
Involved in customer complaint investigation if required
Support the annual product quality reviews if required
Act as back room support during any external audit/inspections
Represent Quality in the project management for any Process/product/system improvement projects
Training of new Quality personnel where appropriate and development of new training
GMP implementation and site-wide Quality Awareness
Liaise with other Department representatives to promote improvements in GMP and Quality standards
Leading and implementing innovation, best practices and solutions for drug product manufacturing in collaboration with Quality teams from the other sister sites
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 the business