- Reference: GY44892
- Job Type: Permanent
- Location: Galway
- Category: Science, Pharmaceutical & Food
Reporting to the Senior Manager Quality Operations Injectable, the Quality Assurance Executive position will support complaints/escalations/FARs investigations, PQR review and batch records review of products manufactured/ packaged by my client’s Affiliate Injectable sites.
- Investigation of product complaints of affiliate sites & associated vendors and of third parties.
- Support the affiliate sites in investigations related to escalations (such as but not limited to OOT / OOS laboratory investigations, process deviations).
- When applicable, file FAR in timely manner and investigate the reported defect.
- Review of Product Quality Review (PQR) Reports for affiliate injectable sites.
- Preparation and review of SOPs
- Preparation of monthly/quarterly/annual KPI/Management review data as required.
- Provide training to QA Regional staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures.
- Liaise with Clinical, Manufacturing and Packaging sites as required.
- Support other activities of the Regional Quality team such as but not limited to :
- Batch records review
- Deviations review
- Product technical files
- Continuous improvement tasks / projects
- Preparation and control of Technical Agreements and Confidentiality Agreements.
- Support Annual Reports submission, Product Development and Product Launch for Injectable Affiliate Sites.
- Support Affiliates Injectable sites inspections if required
- Provide technical transfer and process validation support. Review equipment, process, method validation protocols and reports.
- Review of stability data, stability protocols, stability reports for affiliate Injectable sites
- Perform other duties as assigned.
Skills, Experience and Qualifications:
- Minimum of a Bachelor’s degree (or equivalent) in a life science or pharmacy and 3-5 years of experience in quality control or quality assurance within a pharmaceutical/ medical device company.
- Experience of sterile injectable manufacturing and third party/affiliate site quality management desirable but not essential.
Experience with QC/Manufacturing Deviations
- Experience with Regulatory Bodies
- Quality QA and/or QC experience working in a pharmaceutical GMP environment.
- Experience in QA operational and compliance issues – investigations, complaints, batch review, deviations etc.
- QC experience is an advantage in OOT / OOS / analytical investigations.
- A knowledge of Trackwise software is an advantage.
- As this role supports affiliate injectable sites, an experience in third party manufacturing oversight and/or sterile manufacture is ideally required.
For a confidential discussion and more information on the role/company please email your CV to: email@example.com