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QP / Site QA Manager
| Salary(€): |
0 - 0 |
| Location: |
Europe |
| Ref: |
103744 |
QP / Site QA Manager
The QP QA Site Manager is the first contact with the Medical products Agency (MPA) concerning the Authorisation. You will be the named Qualified Person (QP) on the Manufacturing Authorisation. The QA Site Manager /QP will be the person responsible for all batch certification and connected responsibilities required by 2001/83/EC as amended.
Responsiblities
Management of the site
Personnel management of the site
Ensuring budgets are maintained for the site
Leading development and maintenance of metrics for the site
Primary contact for MPA regarding recall, inspection and MA
Submitting changes affecting the MA to MPA
Maintenance of the Authorisation and ensuring validity (eg scope and expiry)
Maintenance of a batch register
Approval of SOPs
Only delegate QP activities to personnel with the needed and documented training and experience. A delegate should be documented and limited in time.
Approve or reject CMOs, distributors and Contract laboratories for use
Ensure up to date knowledge and experience regarding GMP, GDP and GCP
Performing batch disposition
Managing priorities and tasks in conjunction with CMO
Monitoring daily operations at CMO
Designing, implementing and improving EU Quality Metrics and Quality systems
Reviewing and approving; batch records. Specifications, deviations and change controls
Leading investigations
Leading and facilitating technology transfer, process scale-up and process improvement projects.
Leading meetings and audits
Leading drug product complaints
Approving the Product Quality Review
Leading meetings with external parties and representing the company in a professional manner.
Implementation and maintenance of Technical Quality Agreements as required
Authorised to reject or release batches, both commercial and clinical
The QP should ensure they have appropriate resources to ensure that systems and communication are in place and in operation
Direct access to senior management
Access to any documentation required to fulfill responsibilities
Approve or reject CMOs, distributors and contract laboratories for use covered in the MA
Approve Technical Quality Agreements
Coordinate and attend MPA inspections both in EU and USA.
Education & Experience Requirements
Bachelor’s degree in Pharmacy, Chemistry, Biology or a related discipline
Significant experience working in Quality Assurance, Quality Control, Manufacturing, and working as a Qualified Person to support the manufacturing of biopharmaceuticals.
Experience in people management
Qualified Person eligibility
Thorough understanding of quality systems and cGMPs.
Experience conducting audits as Lead Auditor
Must be able to travel up to 25% (domestic and international)
Please contact Laurentina Kennedy, on 01 2302400 or email your CV to laurentina@rftgroup.ie
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