Batch Record Reviewer/Sr. Batch Record Reviewer Investigator Job in Irvine 92602, California US
Overview:
Teva Parenteral Medicines is a global leader in the manufacture of generic injectable pharmaceuticals. A member of TEVA Pharmaceuticals Industries, the world's leading manufacturer and marketer of generic drugs. The company's mission is to play a leading role in the transformation of the U.S. healthcare system through its preeminence in the development, manufacture and marketing of generic pharmaceuticals. Teva Parenteral Medicines has an excellent opportunity for Batch Record Reviewer/Sr. Batch Record Reviewer Investigator.
This position will be responsible for performing Final Review and Release of finished product. This position ensures that all investigations and any special studies are adequately and appropriately documented and reported in the batch records. This position also assists department management with the review of Batch Records for commercial product launches
Responsibilities:
Responsible for the Final Review of all Batch Records and all other relevant documents associated with the batch. This documentation includes but is not limited to Batch Records, Sterilization Records, Deviation Reports, Equipment charts, Supporting Validation documentation, Chemistry and Microbiology Finished Product Specifications and Data Sheets, Post- Manufacturing Testing-raw materials
Responsible for the Initial Review of all Batch Records for Commercial Distribution, Medias, Stability and Commercial Launches, and all other relevant documents. This documentation includes but is not limited to Batch Records, Sterilization Records, Deviation Reports, Equipment charts, Supporting Validation documentation, Chemical and Microbiological testing. Responsible for the initial review of Batch Records of new developed products intended for Company submissions and Batch Record documentation of new processes.
Works with all facets of the company including technical representatives from manufacturing, validation and the laboratories to assure that investigations are properly performed, that corrective actions are adequate and appropriate and that all issues are resolved in a timely fashion and that any special studies performed in manufacturing are accurately documented and reported.
Provides accurate input into the Releasability of Batches, the manufacturing status of all products by generating on a weekly basis, Oracle Status Reports for Teva products (make to stock) and Contract products (make to order). Updates and maintains these reports via the Oracle database.
Releases Product through the Oracle application system at multiple locations. Runs weekly reports from the Oracle application system for production meetings.
Assists management of Documentation Control/Product Release in special projects as required (relating to contract products, batch record revision, etc.).
Primary Outcomes :
Reviews and Releases all standard Teva/Contract Finished Product for Commercial Distribution.
Supports of all aspects of the Product Release process
Qualifications:
Degee in a scientific discipline or equivalent experience
4-year degree in Science or Life Science field - Preferred
Minimum 5 years of pharmaceutical or related work experience. Formal training with regards to cGMP Regulations and requirements for the
Pharmaceutical Industry.
Good computer skills and ability to work with all levels of personnel.
Must be skilled at problem solving analysis and report writing - Required
Minimum 8 years of Pharmaceutical or related work experience, and requirements as stated above - Preferred
As a member of TEVA Pharmaceutical Industries, Ltd., the world's leading manufacturer and marketer of generic drugs, we regularly seek dedicated and hardworking professionals with the necessary skills for our business.
Teva Parenteral Medicines offers a comprehensive benefit package, including major medical, dental, vision, 401(k) and the opportunity to grow with a dynamic company. For immediate consideration, please visit www.tevausa.com . Click Employment Opportunities, then Positions Available and search for Position 12-8677.
Resumes will be reviewed and qualified candidates will be contacted for pre-screening. Search Firm Representatives Please Read Carefully:
Teva is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails.
All resumes submitted by search firms to any employee at Teva via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Teva. No fee will be paid in the event the candidate is hired by Teva as a result of the referral or through other means.
