The Quality Assurance Specialist supports externally manufactured products. Will be responsible for Batch Reviews, CMO Governance, Quality Support and Deputation with a product portfolio that includes pharmaceutical and biopharmaceutical products.
Preparation of CMO documentation for batch review.
Review of batch records, addressing discrepancies and escalating where required to management.
Preparation of disposition and release certification for reviewed batch records.
Management and oversight of third party supplier activities relating to the manufacture, packaging and testing of product.
Regular telephone and email communication with CMOs to ensure timely manufacture and resolution of quality issues for product.
Continuous monitoring of product and performance from CMOs.
Quality Support and Deputation
Monitoring cold-chain transportation, for both qualification and routine
Input into Technical Quality Agreements
Post-launch support for quality activities in various countries
Management of delegated projects
Audits, Drive the audit readiness programs to ensure audit compliance at all times.
- quality systems management
- Quality assurance
- Batch record review
- change control
- CMO Management
- Quality control
- Document control
- Batch record
Additional Skills & Qualifications:
- Bachelor's Degree in scientific discipline, preferred +3-5years' experience working as QA Specialist
- Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification and document management systems)
- Knowledge of cGMP requirements for pharmaceutical manufacturing and knowledge of GDP and ISO 13485
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.