Featured Advertisers
This job has been removed from the site. Here are the details which were advertised. |
View Similar Jobs View other jobs from this advertiser |
DIRECTOR Q.A. SUPPLY QUALITY MANAGEMENT
Company:RFT GROUP |
||||
Job Reference Number |
14572049 |
Client ID: |
RI/ |
|
Posted On: |
Feb 22 2012 |
|||
Location: |
DUBLIN |
|||
Job Type: |
Permanent |
|||
Salary: |
DIRECTOR PACKAGE |
|||
Benefits: |
|
|||
Our client is a highly profitable fast growing multinational pharmaceutical manufacturer.
Job Spec :
As a member of our clients’ Quality Leadership Team assist in leading a highly matrixed, internally and externally collaborative Quality Assurance and Compliance operations for Supply Quality Management at select CMO sites.
Manage Supplier Qualification program (supplier/vendor audits, remediation, qualification and requalification) supporting CMO/CRO-based clinical and commercial manufacture and supplies.
Collaborate with the company’s Manufacturing and Supply Operations, and CMC teams in developing and implementing product supply strategies.
Provide technical, quality and compliance assessment for evaluation of vendor initiated change controls, deviations, investigations, CAPAs.
Provide Quality Control support for select outsourced product release and stability testing, including quality and compliance assessment of methods transfer, validation and routing testing.
Develop and implement Quality and Compliance improvement programs in partnership with the company’s CMOs in Europe.
Provide Quality and Compliance oversight and ensure a high level of CGMP compliance along entire supply chain.
1. Accountable for overall strategies and management of highly effective and efficient cGMP compliant Supplier Qualification and Supplier Quality Management operation at select sites.
2. Accountable for supplier audit schedules, remediation, quality and CGMP compliance driving regulatory inspection readiness at select sites.
3. Accountable for effective and efficient management of internal (Manufacturing, CMC, R&D) and external (CMOs, Testing Laboratories, Labelling and Packaging, and Shipping service providers) collaborations for high quality. CGMP compliant manufacture and supplies of clinical and commercial products.
4. Integration of Supply Quality Management plans, projects, deliverables with manufacturing schedules and product supply plans consistent with set goals.
5. Responsible for integration and harmonization of CGMP compliant activities across select CMO operations involving manufacture and supply of the drug substance, drug product and finished product to ensure timely release and uninterrupted clinical and commercial supply.
6. Accountable for overseeing CGMP compliant product release and stability testing at select contract laboratories
7. Provide counsel to the company’s CMC and R&D teams in quality and compliance matters.
8. Act in the capacity of the technical experts for quality control, quality assurance and CGMP compliance issues.
9. Responsible for budget plans for Supply Quality Management consistent with set goals.
Person Spec
Experience: 10+ years of experience in QA with 5+ years in Supply Quality Management at EU companies.
· Quality and Compliance experience consistent with world-wide regulatory requirements
· Strong technical knowledge of analytical technologies with a focus on innovation
· Excellent knowledge of pharmaceutical product development process
· Ability to influence CMOs and ex-company collaborations through effective leadership
· Strong leadership abilities required to effectively implement change management strategies
· Demonstrated ability to successfully manage diverse Quality and CGMP compliance practices
Education: BS/MS with Chemistry, Biology, Biotechnology or Pharmaceutical majors.
Cv to gerry@rftgroup.ie 01 2302400 www.rftgroup.ie
