|
|
 |
Let the right jobs and recruiters find you...
- Our advanced "jobs by email" will send you new jobs every day.
- Recruiters will contact you directly about jobs they have available.
- Registration only takes a few minutes, but will save you hours.
|
 |
| Senior Quality Engineer |
Ceredigion (Full Time, Permanent)
|
|
|
Senior Quality Engineer - Ceredigion, Dyfed
My client is an international biopharmaceutical company with operations in Europe, North America, Australia and Japan; this is an opportunity to join an industry leader at an exciting time in their 30 year history.
They are seeking a Senior Quality Engineer to participate and support activities in the Quality Assurance Department to ensure that all goods manufactured and services provided meet quality requirements. This position is a full-time permanent post.
Key Responsibilities
Assist in the maintenance, management, and organisation of the Quality Assurance department ensuring that departmental objectives are implemented in line with the overall Quality/Corporate goals.
Assist in ensuring departmental understanding and compliance with the requirements of cGMP as applied to the company’s product. As needed, assist in providing training and support to departments. Assist in applications for regulatory approval.
Initiate improvements to the Quality Management System, ensuring compliance to all relevant Quality Standards and Regulatory requirements.
Ensure effective coordination and QA leadership for the site CAPA Team, including initiating investigations, root cause analysis, risk assessments and implementation of change controls and Corrective and Preventive Actions, as appropriate; focus on Continuous Improvement opportunities.
Review and assist in process capability studies and statistical techniques as necessary, to support continuous improvement.
Ensure close liaison with Validation group / team and Analytical Development teams.
Evaluate Non Conformances. Identify corrective and preventive action; determine assignable root cause, complete failure investigations and follow up to corrective and preventive actions, ensuring adequate and timely closure.
Review/document Change Control Requests, ensuring compliance with cGMP and quality standard requirements. Follow-up on recommended actions.
Implement Key Performance Indicators. Review and monitor trends, communicating out-of-norm issues to department management. Contribute to and assist in providing quality system training Company wide.
Prepare and present quality reports, data and Key Performance Indicators to management for review / site and corporate Quality Council meetings.
File/archive quality and manufacturing records.
Review and coordinate packaging and labelling change requests, update regulatory authorities as appropriate.
Close interaction with competent authorities and customer services/marketing personnel ensuring import and export documentation is in place to expedite customer’s orders.
Complete customer requests for documentation information to support quality and regulatory requirements. Provide technical reports as appropriate.
Participate in and support internal and external audit program, and/or other audits as needed. Ensure timely, accurate completion of audits.
Assist in the evaluation of customer complaints, ensuring complaint reports are closed out in accordance with the approved procedure. Work in conjunction with other internal and external departments, staff and customer as needed. Ensure the Director of Quality is informed of the progress of complaints at intervals appropriate to the level of the complaint.
Participate in the development, and maintenance of the Company’s Quality System to meet the requirements of the relevant regulatory authorities, Notified Bodies (if applicable) and ISO standards (as applicable) and all other applicable quality and regulatory standards.
Support other departmental activities as requested by department management or designate.
Ensure that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with Company values.
Carry out other reasonable tasks as required.
Education and Experience
Bachelors/Undergraduate Degree in quality or science discipline (chemistry, biology, or medical technology preferred).
Experience in a drug manufacturing, medical device, or biologics industry in Quality Assurance, Quality Control or Quality Engineering position.
Demonstrated knowledge of document control systems.
Experience with internal and external audit processes desired.
Demonstrated knowledge of cGMPs, MHRA, FDA regulations, and SOP’s.
Demonstrated advanced computer skills - Microsoft Office preferred.
|
| |
|
|
|
|
