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QUALITY ASSURANCE MANAGER
Company:BRUNEL RECRUITMENT |
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Job Reference Number |
14276257 |
Client ID: |
RI/890690ENA |
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Posted On: |
Feb 8 2010 |
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Location: |
CORK, CORK |
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Job Type: |
Permanent |
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Salary: |
NEGOTIABLE |
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Quality Assurance Team Lead - Innovation Centre
Reporting to the QA Technical Leader, the Quality Assurance Team Lead shall lead and support from a Quality perspective.
MAIN DUTIES & RESPONSIBILITIES:
* Manage the activities of a defined team of QA personnel. Management responsibilities to include day to day work allocation and prioritisation, performance and output quality review, coaching, training, internal communications and general personnel assistance during the course of their duties
* Support varies work streams as required per defined project plans.
* Assist and where appropriate lead in the compilation and execution of validation protocols for new product/processes and software. Ensure correct implementation as per standard validation procedures. Re-validate as required due to engineering change, deviation analysis or upgrade in systems and materiel. Manage QA related change control for specific projects as directed
* Co-ordinate product/technology transfer between facilities from a QA perspective. Develop and utilise DFMEA/PFMEA and other QA risk analysis techniques in order to minimise potential risk during development/implementation activity.
* Be responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues.
* Actively support all defined goals and objectives of the Innovation Centre
* Lead QA Innovation Centre projects for the introduction of new product introductions.
* Responsible for recruitment, development, and training of all QA personnel
* Work closely with other areas of QA and the business to promote compliance
* Implement and maintain CSOPs to ensure total compliance in areas of responsibility for the Innovation Centre
* Resolve problems & eliminate constraints to ensure project targets are met.
* Ensure the Innovation Centre complies with GMP, ISO and QSR requirements.
* Ensure effective and timely communications both oral and written (weekly/monthly written reports, Project updates, daily / weekly direction to Quality personnel)
* Ensure effective and timely closure on all Corrective Action Requests, Failure Investigation Reports and Close Call Investigation.
* Maintains standards of housekeeping & GMP requirements
* Represent the Quality function as required by management
* Ensure that all Health, Safety and Environmental requirements are fulfilled.
* Ensure compliance with all Documented Quality system, as per SEP 180 i.e. FDA QSR's and ISO 13485/9001 requirements etc. during day to day and assigned audit/CAPA activities
KEY COMPETENCIES REQUIRED
* Demonstrate standards of leadership -
* Culturally aware
* Flexible
* Team player
* Good influencing skills
* Firm when required - business balance
* Project Management skills
* Good generalist (experienced quality person)
* Methodical
* Defuser, not inflamer
* Good communicator
* Politically sensitive
* Travel Flexibility
QUALIFICATIONS & EXPERIENCE
A degree level or similar qualification in Material Sciences and/or Biomedical/Chemical engineering.
Minimum 3 years experience in a senior quality role within a regulated industry.
Minimum 3 years experience in a managerial position.
Proven ability to successfully manage new product development in the Medical Device/Pharma Industry. Proven knowledge and ability regarding product verification and process validations.
Proven knowledge of FDA and MDD GMP requirements regarding medical Devices
Proven experience in biomedical/pharma industry
If you are interested in this role and have the required experience please apply in confidence.
Eileen Nyhan
