QUALITY ASSURANCE SPECIALIST, API EXTERNAL MANUFACTURING required by CareerWise Recruitment for our multinational Life Sciences client at their facility in Co. Cork...initial 12 month contract on offer.
The QUALITY ASSURANCE SPECIALIST, API EXTERNAL MANUFACTURING will need to have large molecule / bio experience with a minimum of 5 years' experience required. Experience with external OR 3rd party manufacturers would be a distinct advantage.
NOTE:
No sponsorship is provided for this role so applicants need to already have Irish / EU citizenship OR the relevant Stamp / Visa in place.
RESPONSIBILITIES:
* Serve as a liaison between Contract Manufacturing organizations and the client.
* Provide quality oversight of CMs including being the initial point of contact for all quality-related issues.
* Escalate quality issues at CMs to QA management.
* Assist in the establishment and revisions of Quality Agreements with affiliates and customers.
* Ensure compliance to Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
* Provide quality oversight of APIEM Quality Plans
* Coordinate and perform QA responsibilities of API shipments.
* Participate in regulatory inspection preparations with CMs. Provide on-site support during inspections.
* Participate on the Technical Review Board
* Evaluate and disposition API batches, if required.
* Ensure that documented checks have been completed for the Certificates of Testing and Certificates of Environmental Monitoring (where applicable), and deviations, changes and batch documentation that demonstrates requirements have been met prior to batch release.
* Provide quality support of API manufacturing with the focus on holistic review of key activities associated with or impacting the manufacturing processes including deviations, change controls and countermeasures.
* Assess the impact of deviation investigations and changes and ensure that all appropriate records are documented and retrievable.
* Ensure all processes are in an appropriate state of control.
* Maintain awareness of external regulatory agency findings which individually or collectively reference the quality of the product.
* Review and approve documents including, but not limited to, procedures, master production records, change control proposals, deviations, equipment qualifications, analytical methods and computerized system validations.
* Participate in APR activities.
* Participate in projects to improve productivity.
* Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
REQUIREMENTS:
* BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
* Previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, QC, QA or Engineering.
* Experience in quality support for Quality Control activities
* Thorough technical understanding of quality systems and regulatory requirements.
* Knowledge of pharmaceutical manufacturing operations.
Please call Conor Twomey today for further information on or email:
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.