Sr. Product Release Specialist – Valeant – Bridgewater, NJ, USA
The Senior QA Product Release Specialist will work in the External QA team of Valeant United States (US) Quality Assurance. This unit includes oversight of external drug product manufacturing at contract manufacturers, laboratory operations, internal warehouse operations, packing and labeling operations, batch release and logistics performed on behalf of Valeant. This unit also provides QA support for Quality Control (drug substance, drug product testing and stability).
This individual will support all disposition activities related to external commercially manufactured, drug substance, drug product and finished drug. Responsible for adhering to domestic and international GMP regulations and cGMP’s, company policies.
The position is responsible for review and release of all records associated with external manufactured products. Supports all pharmaceutical supply channels including, cold chain and evaluation of cold chain as related to movement of plasma and plasma derived drug product to the end user. The individual may be responsible for, but is not limited to:
- Product batch disposition preparation in accordance with priorities and inventory demands.
- Conducting record review of executed batch records from CMO operations; if required support CMO packaging & labeling record review,
- Performing review of records e.g CoA, CoC, testing results,…
- Review all non-conformances/ deviations
- May own/ approve CAPAs associated within the QA unit
- Review drug product annual review report sections
- Understanding of GMP’s
- Initiate and/or review, non-conformances, CAPA’s and Change Management
- Supports departmental projects, as needed
Scope of position:
The scope of this position is directly related to the Valeant North America External Manufacturing and the EMEA Supplier Quality Organization.
The position has no supervisory responsibilities.
Periodic domestic travel is required for business meetings with regional Quality team, corporate peers/collaborators, vendors/contractors, and to stay current with professional development opportunities
Key relationships:Internal Customers/Business Partners:
Supply Chain Partners
Regulatory Affairs (NA)
Research and Development
Global Product Surveillance and Safety
Compliance Senior Leadership (NA)
External Customers and Business Partners:
Finished Goods / External Manufacturing Suppliers
EMEA Supplier Quality
Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
Training to GMP requirements per 21 CFR 210 & 211
Demonstrated organizational skills, critical thinking/problem solving, multi-tasking, proactively identifying/addressing issues.
Knowledgeable of statistical and trending techniques.
Demonstrated ability to actively lead lessons learned, gap analysis, action planning, and investigations.
Training in problem solving tools (Process Mapping, Histograms, FMEA, Risk Assessment, Cause & Effect Diagrams, PCDA, Pareto Analysis),
Technology Skills: Windows, MS Word, MS Excel. Training to include local software systems like Catsweb, Kintana, and Documentum.
Minimum requirements include a Bachelor’s degree in a technical area, preferably a biological science discipline and a minimum of 3 years of experience in the biopharmaceutical industry.