- JN -012024-1953988
- Jan 15, 2024
This is an excellent opportunity to join a high profile global manufacturer based out of Cork. This expanding team have strong working relations with both internal and external business stakeholders.
The External Manufacturing Quality Assurance Specialist (focusing on API) provides support to all quality activities at the various Contract Manufacturing organisations (CMOs). This individual's position is essential for ensuring that all batches meet specifications, are manufactured in accordance with the validated process and are compliant to cGMPs and regulatory commitments.
A bit more about the role:
- Serve as a liaison between the business and contract manufacturers (CMOs).
- Provide quality oversight of CMOs including being the initial point of contact for all quality-related issues and escalate any issues as required.
- 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 Quality Plans.
- Coordinate and perform QA responsibilities of API shipments.
- Participate in regulatory inspection preparations with CMOs. Provide on-site support during inspections.
- Participate on the Technical Review Board.
- 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.
- 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; projects to improve productivity; Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
- BS (Hons) in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
- 4+ years of previous GMP manufacturing knowledge and/or experience in API or finished product manufacturing, ideally within a QA role.
- Experience in quality support for Large molecule Drug Substance manufacturing would be highly desirable
- Thorough technical understanding of quality systems and regulatory requirements.
- Knowledge of pharmaceutical manufacturing operations.
- Demonstrated coaching and mentoring skills.
- Experience in root cause analysis.
- Strong attention to detail and communication skills
- Proficiency with computer system applications.
- Excellent interpersonal skills and networking skills.
- Ability to organise and prioritise multiple tasks.
- Ability to influence diverse groups and manage relationships.
- Travel up to 20% (mostly in Europe and Asia)
- Base location is Cork but hybrid working is on offer
If you would like to find out more about this role please click the 'Apply Now' button below or reach out to Kellie on 021 2300 300.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.