Quality Assurance Manufacturing Manager (sterile manufacturing)
- Employer
- Manpower Ireland
- Location
- Dublin West, Dublin
- Salary
- Negotiable
- Closing date
- 19 Jul 2019
View more
- Sector
- Scientific
- Job Type
- Permanent
- Hours
- Full-time
Quality Assurance Manufacturing Manager is required for a new purification and aseptic filling 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.
Reporting directly to the Technical Director. To complete and support activities within the Quality Department relating to GMP Compliance and to provide Quality support for the aseptic manufacturing operations.
Extensive knowledge and understanding of Annex 1 and aseptic regulatory requirements is essential.
QP qualification will be considered an advantage.
KEY RESPONSIBILITIES
1 Communication:
Daily briefing on Quality batch review/approval
Provide quality performance information as required
Ensure regular Quality interaction with other Departments
2 Management:
Build organizational competency and succession plans.
Involvement in interviewing/selection process of hiring or promoting department personnel.
Conduct performance reviews of personnel
3 Quality Assurance Activities:
Support method transfer plans, qualification and sampling plans for water systems, raw materials, environmental monitoring, in- process sampling
Assist and participate in qualification of cleaning processes, clean rooms and sterilisation processes, aseptic gowning and other qualification processes where required.
Reviewing and approving SOP's, validation protocols and reports and other GMP documentation
Review of Batch Records
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
Ensure compliance with company quality requirements and customer quality requirements.
Provide 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
Involved in customer complaint investigation if required
Support the annual product quality reviews if required
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 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
Perform internal audits as per the agreed audit plan.
Perform other duties as required by Management
Contact Ann Marie Corcoran for more information
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