QA Associate II/III

QA Associate II/III

 

The QA Associate will be responsible for maintaining the Jazz Pharmaceuticals? Quality System procedures.  He/she will organize training activities related to Jazz Pharmaceuticals quality procedures, government regulations and regulatory compliance. The QA Associate will directly manage the following quality functions with minimum supervision: Batch Record Review and Approval, CAPA, Complaint Handling, Clinical and Commercial Product Release, Annual Product Review, Quality Agreements and Supplier Audits.

 

The QA Associate will:

 

?  Develop, implement and maintain standard operating procedures (SOPs) for oversight of manufacturing, testing and release of Product at Contract Manufacturing Sites (CMS) for Clinical and Commercial use.

?  Review and approve master batch records, product specifications and SOPs.

?  Review and approve executed batch records for API, intermediates and drug product (bulk and finished goods) and issue C of A to release clinical and commercial product for human use.

?  Coordinate shipment of QC, Clinical, Stability samples and Commercial product.

?  Write and revise Quality systems SOPs as necessary to maintain compliance to cGMPs.

?  Develop an Electronic database to log and track complaints, deviations (CAPA) and follow ups.

?  Perform/coordinate investigations related to OOS, product complaints, and deviations.

?  Establish and monitor Quality Assurance programs and procedures at Contract manufacturing/testing facilities to ensure conformance and compliance to Jazz Pharmaceuticals Quality Policies, procedures and regulatory standards.

?  Perform Quality audits of contract manufacturing sites, test laboratories, API and raw material vendors to ensure compliance to cGMPs and Compliance.

?  Partner with Regulatory Affairs, Development and Operations group for the preparation of regulatory submissions (SNDA, PAS, and CBEs etc) related to the product/processes.

?  Report to the QA Manager.

 

ESSENTIAL REQUIRMENTS:

 

Minimum B.S/B.A. degree in Chemistry, Biochemistry, Engineering or related science field. A minimum of 7 years experience in Pharmaceutical or biotechnology industry (preferably in commercial operations) with at least 5 years of experience in Quality Assurance, or Quality Control department.  Demonstrated knowledge of cGMPs, GLP, ICH, and other regulatory requirements for the manufacture, testing, and release of pharmaceutical products. Ability to effectively deal and negotiate with representatives of various government and auditing agencies.


Proven proficiency using MS Word, Excel and PowerPoint.

 

Excellent written, oral, communication and organizational skills.

 

Must be able to travel domestically and internationally (25 %).