External Site Quality Leader
|Title||:||External Site Quality Leader|
|Sector||:||Manufacturing & Production
Scientific & Laboratory
Role of this positionThe External Site Quality Leader will have a strong Sterile / Aseptic background. Experience in with dealing with contract manufacturers would be preferable. Qualified Persons (QP), would be an added bonus but not a requirement for the role. The role also offers 25% travel to visit CMOs. Details of the role are as follows:
- Responsibility for quality oversight of External Party (s) (EP) that manufacture sterile pharmaceutical products, ensuring that the goods were produced in conformance to all applicable policies and procedures and compliance with all governing regulations. Prior to shipment, he/she will assure that products manufactured by the plant have the correct quality and identity, meet all pertinent specifications and special requirements, and have been produced by approved processes and under proper conditions.
- Has responsibility for Quality Assurance and control functions to include direct support to EPs, coordination and oversight for product testing, as well as other relevant components as determined by applied Calibrated Quality Oversight. These components may include review of batch documentation and deviation investigations.
- Monitors efforts to improve the EP's quality and reliability through ongoing oversight and formal communication programs and forums.
- Provides support to the EP's to facilitate and validate new product introductions
- Will provide on site quality support for all Regulatory Authority Inspections at the EP.
- Conducts quality due diligence assessments for pre-approval considerations of new EP's
- Coordinates significant investigations including Fact Findings and product recalls as needed.
- Closely collaborates with appropriate business and operations areas to achieve Manufacturing Division objectives.
- Assures the development and maintenance of a Quality Agreement with the EP. Provides input into the development of contractual agreements with the EP
- Executes a program of calibrated Quality oversight based on the product type, capabilities, and quality and compliance performance of the EP.
- Directs the EQA EU cGMP program including maintaining permanent inspection readiness at sterile Eps will primarily be responsible for maintaining and improving where necessary all quality systems and monitoring production process for compliance to implemented process controls.
- Degree or 3rd level qualification (Chemistry, Microbiology, Production, Mechanical, Minimum of 10 Years of Experience in the Pharmaceutical industry, including Aseptic Processing and Quality Operations experience.
- People management experience required.
- Experience in Contract Manufacturing Oversight (CMOs, Labs, etc.) required.
- Quality Agreement negotiation and implementation skills are required.
- Strong understanding of Sterile Standards required.
- Qualified Person (desirable but not a mandatory)
Please call Michael Hanrahan today for further information on 021-2019817 or email: firstname.lastname@example.org
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.