LSC has an exciting opportunity for a Quality Assurance External Manufacturing representative to join a leading pharmaceutical company in Cork.
This is is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture.
If you have a minimum of 3 years of experience working in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
Description:
The DRY External Manufacturing Quality Assurance Contractor provides support to all quality activities at Contract Manufacturing organizations (CMs). The QA Contractor'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.
Key Objectives/Deliverables:
* 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).
* 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.
* Ensure all processes are in an appropriate state of control.
* Participate in APR activities.
* Participate in Joint Process (JPT) and Post Launch Optimization (PLOT) Teams.
Basic 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
Additional Preferences:
* Experience in quality support for Quality Control activities
* Knowledge of pharmaceutical manufacturing operations.
* Demonstrated coaching and mentoring skills.
* Experience in root cause analysis.
* Demonstrated application of statistical skills.
* Demonstrated strong written and verbal communications skills.
* Strong attention to detail.
* Proficiency with computer system applications.
* Excellent interpersonal skills and networking skills.
Education Requirements:
* BS in a science-related field such as Pharmacy, Chemistry, Biological Sciences or related Life Sciences.
Note: Are you currently eligible to work in Ireland?
As this is a contract opportunity you will need to hold a valid Stamp 1G/Stamp 4 visa to apply!
Apply via this advert or contact Siobhan Cummins at LSC on 021 4777329 if you have any more questions about this role!
