- Insmed Incorporated (San Diego, CA)
- …hands-on experience in a validation role with responsibility for computer systems specifically LIMS, eTMF/CTMS, and other Clinical/Manufacturing systems ... Provide strategic leadership and decision making on CSV strategy Develop risk-based validation strategies for system implementation and changes following CSV… more
- Cipla (Fall River, MA)
- …documents. Preparation of qualification and validation documents of equipment and computer system . Preparation and qualification of e-batch record & e-Log ... Job Title : Mfg. Validation Engineer FLSA Classification : Professional, Exempt Work...with experience in generic pharmaceutical manufacturing. Technical Knowledge and Computer Systems Skills Excellent communication skills, drive,… more
- Cipla (Hauppauge, NY)
- …General: 8:30AM - 5:00PM (may vary based on business needs) Reports To : QA Validation Manager Salary Range: $68,000 - $74,600 Purpose: The incumbent to this ... (DPI, MDI, oral solid or Injectables preferred). Technical Knowledge and Computer Systems Skills Effective interpersonal relationship skills and the… more
- ValSource, Inc. (Rahway, NJ)
- …and cleaning validation is desirable. Working knowledge of process automation and computer system validation concepts, GAMP methodologies, 21 CFR Part 11 ... our regions in the US. The Commissioning, Qualification & Validation (CQV) Project Manager will interface with...guidelines, client requirements, and company SOPs. Field Verifications and system walkdowns to confirm systems meet design… more
- Insmed Incorporated (NJ)
- …years' experience in a management validation role with responsibility for computer systems specifically eTMF, CTMS, EDC, IRT, eCOA/ePRO and other ... will include, but not necessarily limited to the following: Develop risk-based validation strategies for system implementation and changes following CSV SOPs… more
- Endo International (St. Louis, MO)
- …and review. The position will also have responsibilities for the review/approval of validation activities for enterprise computer system software and other ... Interaction with colleagues at other sites involved with enterprise computer system software, Data Integrity, and equipment/process validation needs. + Need… more
- Merck & Co. (Durham, NC)
- …above floor level. Walking, bending, crawling, and stooping is required.-Proficiency in computer systems and applications including but not limited to:- ... steam generators, Water-For-Injection generation/distribution, reverse osmosis skids, compressed gas systems )Automated Systems (eg Distributed Control System … more
- BeOne Medicines (San Mateo, CA)
- Senior Manager , CDM Systems Administrator is responsible for leading and oversight of Data Management systems including Oracle LSH/DMW, Medidata Rave and any ... of MDM and downstream processes that impact data management systems + Develop and maintain user access management documents...of clinical database design / study build / data validation and system interoperability + Competence with… more
- Cipla (Fall River, MA)
- …Manufacturing Practices (GMP)/Good Distribution Practices (GDP), etc. Technical Knowledge and Computer Systems Skills Understanding of machines used in ... 5:00PM (may vary based on business needs) Reports To : Quality Assurance Manager Salary Range: $72,800 - $93,600 Purpose: The QA operation specialist (MDI) position… more
- Integra LifeSciences (Princeton, NJ)
- …or more of the areas listed below. + Controlled environment monitoring + Water system monitoring + Bacterial endotoxin test method validation and monitoring + ... direct supervision of Director, Quality Reliability Microbiology, the Sr. Manager , Microbiology Reliability - Tissue Technology will have supervisory… more
