Quality Assurance Specialist – API
We are looking for a QA Specialist to join a Cork-based biopharma manufacturing client for a 12‑month initial contract role.
Responsibilities
* Provide support to all quality activities at Contract Manufacturing organizations (CMs).
* Ensure that all batches meet specifications, are manufactured in accordance with the validated process, and are compliant with cGMPs and regulatory commitments.
* Act as the initial point of contact for all quality‑related issues at CMs.
* Escalate quality issues at CMs to QA management.
* Assist in the establishment and revision of Quality Agreements with affiliates and customers.
* Ensure compliance with Quality Agreements and Manufacturing Responsibilities Documents (MRDs).
* Coordinate and perform QA responsibilities of API shipments.
* Participate in regulatory inspection preparations with CMs and provide on‑site support during inspections.
* Ensure that documented checks have been completed for Certificates of Testing, Certificates of Environmental Monitoring (where applicable), deviations, changes, and batch documentation that demonstrates requirements have been met prior to batch release.
* Provide quality support of API manufacturing with a focus on holistic review of key activities associated with or impacting the manufacturing processes, including deviations, change controls, and countermeasures.
Requirements
* BS in a science‑related field such as Pharmacy, Chemistry, Biological Sciences, or related Life Sciences.
* Minimum 5 years of large‑molecule/bio experience.
* Experience with external or third‑party manufacturers is a distinct advantage.
* Thorough technical understanding of quality systems and regulatory requirements.
Please call Diarmuid Buckley today for further information on 021-4355432 or email: dbuckley@careerwise.ie
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