Quality Assurance Manufacturing Manager (sterile manufacturing)

Location
Dublin West, Dublin
Salary
Negotiable
Posted
12 Jul 2019
Closes
19 Jul 2019
Ref
QA Mgr
Contact
Ann Marie Corcoran
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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